What should I do if I have an EDAN Vital Signs Monitor?

Stop using the device immediately and contact Edan Diagnostics or your healthcare provider for further instructions.

What are the risks associated with the M3A model?

The M3A model has potential cybersecurity vulnerabilities that may affect the accuracy of physiological measurements.

How can I return my EDAN monitor for a refund?

Follow the recall instructions provided by Edan Diagnostics to initiate the return process.

Are there any reported injuries related to this recall?

No injuries or incidents related to this recall have been reported so far.

When was the recall issued?

The recall was issued on October 24, 2025, following FDA notifications.

Where can I find more information about the recall?

More details can be found on the FDA's website or by contacting Edan Diagnostics directly.

Is it safe to use my monitor if it appears to be functioning normally?

It is not safe to use the monitor, as the cybersecurity vulnerabilities may compromise its effectiveness.

What are the signs of a faulty monitor?

Users should look out for inaccurate readings or software malfunctions.

Will I get a refund for the returned monitor?

Yes, users are entitled to a full refund regardless of whether they have a receipt.

How long will it take to process my refund?

Typically, the processing time for refunds is around 4-6 weeks.

HIGHOctober 24, 2025

EDAN Recalls Vital Signs Monitor Due to Cybersecurity Issues

EDAN recalled 12,201 Vital Signs Monitors on October 24, 2025, due to potential cybersecurity vulnerabilities. The affected M3A model poses a high risk to patient safety by compromising monitoring accuracy. Users must stop using the devices immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date: October 24, 2025
Hazard Level: HIGH
Brand: Edan Diagnostics
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Edan Diagnostics or your healthcare provider for instructions. Notification method: Letter

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Product Details

The recall affects the EDAN Vital Signs Monitor, Model M3A. The device measures blood pressure, blood oxygen saturation, and temperature. This model was distributed across the U.S. and Mexico.

The Hazard

The recall stems from an FDA It Has Come to Our Attention Letter regarding potential cybersecurity issues. These vulnerabilities may impact the accuracy of physiological readings.

Reported Incidents

As of now, no specific incidents or injuries related to this recall have been reported. The risk level remains high due to potential exposure to cybersecurity threats.

What to Do

Stop using the EDAN Vital Signs Monitor immediately. Contact Edan Diagnostics or your healthcare provider for detailed recall instructions and follow the provided guidance.

Contact Information

For more information, contact Edan Diagnostics at their official website or through the FDA link provided in the recall notification.

Key Facts

Recall date: October 24, 2025
Quantity recalled: 12,201 units
Affected model: M3A
Distributed in multiple U.S. states and Mexico
Reported incidents: None

View Original Recall on FDA - Medical Devices

Browse More Recalls

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeVital Signs Monitor

Product Details

Brand

Edan Diagnostics

Categories

Health & Personal Care Medical Devices

Model Numbers

EDAN Model: M3A UDI-DI code: 06944413800786 Serial/Lot Numbers: 260760-M16406920062 260760-M16406920035 260760-M16406920036 260760-M16406920037 260760-M16406920038 260760-M16406920039 260760-M16406920040 260760-M16406920041 260760-M16406920042 260760-M16406920043 260760-M16406920044 260760-M16406920045 260760-M16406920046 260760-M16406920047 260760-M16406920048 260760-M16406920049 260760-M16406920050 260760-M16406920051 260760-M16406920052 260760-M16406920053 260760-M16406920054 260760-M16406920055 260760-M16406920056 260760-M16406920057 260760-M16406920058 260760-M16406920059 260760-M16406920060 260760-M16406920061 260760-M16406920034 260760-M16406920033 260760-M16406920001 260760-M16406920031 260760-M16406920063 260760-M16406920002 260760-M16406920003 260760-M16406920004 260760-M16406920005 260760-M16406920006 260760-M16406920007 260760-M16406920008 260760-M16406920009 260760-M16406920010 260760-M16406920011 260760-M16406920012 260760-M16406920013 260760-M16406920014 260760-M16406920015 260760-M16406920016 260760-M16406920017 260760-M16406920019 260760-M16406920020 260760-M16406920021 260760-M16406920022 260760-M16406920023 260760-M16406920024 260760-M16406920025 260760-M16406920026 260760-M16406920027 260760-M16406920028 260760-M16406920029 260760-M16406920030 260760-M16406920032 260760-M16406920064 260760-M16406920018 260760-M16406920066 260760-M16406920065 260760-M16406920070 260760-M16406920069 260760-M16406920068 260760-M16406920067 260084-M16408640030 260084-M16408640029 260084-M16408640028 260084-M16408640004 260084-M16408640026 260084-M16408640027 260084-M16408640023 260084-M16408640022 260084-M16408640021 260084-M16408640020 260084-M16408640019 260084-M16408640018 260084-M16408640017 260084-M16408640016 260084-M16408640015 260084-M16408640014 260084-M16408640012 260084-M16408640013 260084-M16408640010 260084-M16408640025 260084-M16408640024 260084-M16408640001 260084-M16408640011 260084-M16408640003 260084-M16408640002 260084-M16408640006 260084-M16408640007 260084-M16408640008 260084-M16408640009 260084-M16408640005 260760-M16604770010 260760-M16604770009 260760-M16604770008 260760-M16604770007 260760-M16604770006 260760-M16604770005 260760-M16604770002 260760-M16604770003 260760-M16604770001 260760-M16604770011 260760-M16604770004 260760-M16604770012 260760-M16604770014 260760-M16604770015 260760-M16604770016 260760-M16604770017 260760-M16604770018 260760-M16604770019 260760-M16604770020 260760-M16604770013 260760-M16604780026 260760-M16604780021 260760-M16604780022 260760-M16604780023 260760-M16604780024 260760-M16604780025 260760-M16604780027 260760-M16604780033 260760-M16604780029 260760-M16604780030 260760-M16604780031 260760-M16604780032 260760-M16604780020 260760-M16604780034 260760-M16604780035 260760-M16604780028 260760-M16604780019 260760-M16604780013 260760-M16604780017 260760-M16604780001 260760-M16604780002 260760-M16604780003 260760-M16604780004 260760-M16604780005 260760-M16604780036 260760-M16604780007 260760-M16604780008 260760-M16604780009 260760-M16604780010 260760-M16604780011 260760-M16604780012 260760-M16604780014 260760-M16604780015 260760-M16604780016 260760-M16604780018 260760-M16604780006 260760-M16604780037 260760-M16604780039 260760-M16604780063 260760-M16604780064 260760-M16604780065 260760-M16604780066 260760-M16604780067 260760-M16604780068 260760-M16604780038 260760-M16604780070 260760-M16604780061 260760-M16604780071 260760-M16604780073 260760-M16604780074 260760-M16604780075 260760-M16604780076 260760-M16604780077 260760-M16604780078 260760-M16604780079 260760-M16604780080 260760-M16604780072 260760-M16604780060 260760-M16604780069 260760-M16604780058 260760-M16604780040 260760-M16604780041 260760-M16604780042 260760-M16604780043 260760-M16604780044 260760-M16604780045 260760-M16604780059 260760-M16604780047 260760-M16604780048 260760-M16604780046 260760-M16604780050 260760-M16604780049 260760-M16604780056 260760-M16604780055 260760-M16604780054 260760-M16604780053 260760-M16604780052 260760-M16604780057 260760-M16604780062 260760-M16604780051 260760-M16807410004 260760-M16807410005 260760-M16807410006 260760-M16807410003 260760-M16807410007 260760-M16807410008 260760-M16807410009 260760-M16807410010 260760-M16807410011 260760-M16807410012 260760-M16807410013 260760-M16807410022 260760-M16807410015 260760-M16807410016 260760-M16807410017 260760-M16807410018 260760-M16807410019 260760-M16807410020 260760-M16807410021 260760-M16807410023 260760-M16807410025 260760-M16807410026 260760-M16807410002 260760-M16807410014 260760-M16807410001 260760-M16807410024 260760-M16907000044 260760-M16907000043 260760-M16907000042 260760-M16907000041 260760-M16907000040 260760-M16907000039 260760-M16907000038 260760-M16907000037 260760-M16907000036 260760-M16907000035 260760-M16907000034 260760-M16907000033 260760-M16907000032 260760-M16907000031 260760-M16907000030 260760-M16907000029 260760-M16907000028 260760-M16907000027 260760-M16907000026 260760-M16907000025 260760-M16907000024 260760-M16907000023 260760-M16907000022 260760-M16907000021 260760-M16907000020 260760-M16907000019 260760-M16907000018 260760-M16907000015 260760-M16907000017 260760-M16907000016 260760-M16907000013 260760-M16907000001 260760-M16907000002 260760-M16907000003 260760-M16907000004 260760-M16907000005 260760-M16907000006 260760-M16907000007 260760-M16907000008 260760-M16907000009 260760-M16907000012 260760-M16907000011 260760-M16907000014 260760-M16907000010 260727-M16704280010 260727-M16704280031 260727-M16704280024 260727-M16704280028 260727-M16704280023 260727-M16704280032 260727-M16704280027 260727-M16704280026 260727-M16704280022 260727-M16704280021 260727-M16704280020 260727-M16704280018 260727-M16704280017 260727-M16704280016 260727-M16704280015 260727-M16704280014 260727-M16704280025 260727-M16704280001 260727-M16704280003 260727-M16704280008 260727-M16704280013 260727-M16704280034 260727-M16704280101 260727-M16704280036 260727-M16704280108 260727-M16704280107 260727-M16704280106 260727-M16704280105 260727-M16704280104 260727-M16704280103 260727-M16704280029 260727-M16704280099 260727-M16704280097 260727-M16704280095 260727-M16704280035 260727-M16704280085 260727-M16704280081 260727-M16704280077 260727-M16704280090 260727-M16704280054 260727-M16704280037 260727-M16704280038 260727-M16704280062 260727-M16704280040 260727-M16704280041 260727-M16704280042 260727-M16704280039 260727-M16704280044 260727-M16704280046 260727-M16704280047 260727-M16704280048 260727-M16704280050 260727-M16704280043 260727-M16704280030 261023-M16B03030002 261023-M16B03030001 260084-M16B03200001 260084-M16B03200003 260760-M16B03190015 260760-M16B03190016 260760-M16B03190017 260760-M16B03190018 260760-M16B03190019 260760-M16B03190020 260760-M16B03190021 260760-M16B03190022 260760-M16B03190023 260760-M16B03190024 260760-M16B03190025 260760-M16B03190026 260760-M16B03190027 260760-M16B03190028 260760-M16B03190029 260760-M16B03190030 260760-M16B03190031 260084-M16B03200002 260760-M16B03190033 260760-M16B03190034 260760-M16B03190035 260760-M16B03190036 260760-M16B03190037 260760-M16B03190038 260760-M16B03190039 260760-M16B03190014 260760-M16B03190013 260760-M16B03190032 260760-M16B03190011 260760-M16B03190012 260084-M16B03200005 260084-M16B03200006 260084-M16B03200007 260084-M16B03200008 260084-M16B03200009 260084-M16B03200010 260084-M16B03200011 260084-M16B03200012 260084-M16B03200013 260084-M16B03200014 260084-M16B03200015 260084-M16B03200016 260084-M16B03200004 260084-M16B03200018 260084-M16B03200017 260760-M16B03190009 260760-M16B03190008 260760-M16B03190006 260760-M16B03190005 260760-M16B03190007 260760-M16B03190003 260760-M16B03190002 260760-M16B03190001 260084-M16B03200020 260084-M16B03200019 260760-M16B03190004 260760-M16B03190010 260760-M16B08990011 260760-M16B08990012 260727-M16704280078 260727-M16704280079 260727-M16704280076 260727-M16704280075 260727-M16704280074 260727-M16704280073 260727-M16704280072 260727-M16704280071 260727-M16704280070 260727-M16704280069 260727-M16704280068 260727-M16704280067 260727-M16704280066 260727-M16704280065 260727-M16704280064 260727-M16704280063 260727-M16704280061 260727-M16704280060 260727-M16704280059 260727-M16704280058 260727-M16704280057 260727-M16704280056 260727-M16704280055 260727-M16704280053 260727-M16704280052 260727-M16704280051 260727-M16704280080 260727-M16704280045 260727-M16704280082 260727-M16704280084 260760-M16B08990010 260760-M16B08990009 260760-M16B08990008 260760-M16B08990007 260760-M16B08990006 260760-M16B08990005 260760-M16B08990004 260760-M16B08990003 260760-M16B08990002 260760-M16B08990001 260084-M16B09000003 260084-M16B09000002 260084-M16B09000001 260727-M16704280102 260727-M16704280100 260727-M16704280098 260727-M16704280096 260727-M16704280094 260727-M16704280093 260727-M16704280092 260727-M16704280091 260727-M16704280089 260727-M16704280088 260727-M16704280087 260727-M16704280086 260727-M16704280083 260727-M16704280033 260727-M16704280049 260727-M16704280012 260760-M16B08990039 260760-M16B08990038 260760-M16B08990037 260760-M16B08990036 260760-M16B08990035 260760-M16B08990034 260760-M16B08990033 260760-M16B08990032 260760-M16B08990031 260760-M16B08990030 260760-M16B08990029 260760-M16B08990028 260727-M16704280019 260760-M16B08990027 260760-M16B08990025 260760-M16B08990024 260760-M16B08990023 260760-M16B08990022 260760-M16B08990021 260760-M16B08990020 260760-M16B08990019 260760-M16B08990018 260760-M16B08990017 260760-M16B08990016 260760-M16B08990015 260760-M16B08990014 260760-M16B08990026 260760-M16B08990041 260760-M16B08990040 260727-M16704280011 260727-M16704280009 260727-M16704280007 260727-M16704280006 260727-M16704280005 260727-M16704280004 260727-M16704280002 260760-M16B08990013 261023-M16C08910003 261023-M16C08910002 261023-M16C08910001 260760-M16C08890025 260760-M16C08890024 260760-M16C08890022 260760-M16C08890023 260084-M16C08900001 260084-M16C08900003 260084-M16C08900004 260084-M16C08900005 260760-M16C08890001 260760-M16C08890002 260760-M16C08890003 260760-M16C08890004 260760-M16C08890005 260760-M16C08890006 260760-M16C08890007 260760-M16C08890008 260760-M16C08890009 260084-M16C08900002 260760-M16C08890011 260760-M16C08890010 260760-M16C08890020 260760-M16C08890019 260760-M16C08890021 260760-M16C08890017 260760-M16C08890018 261023-M16C08910004 260760-M16C08890015 260760-M16C08890014 260760-M16C08890013 260760-M16C08890012 260760-M16C08890016 260084-M16C12980008 260084-M16C12980001 260084-M16C12980006 260084-M16C12980035 260084-M16C12980036 260084-M16C12980022 260084-M16C12980028 260084-M16C12980037 260084-M16C12980038 260084-M16C12980002 260084-M16C12980011 260084-M16C12980027 260084-M16C12980032 260084-M16C12980017 260084-M16C12980031 260084-M16C12980007 260084-M16C12980020 260084-M16C12980024 260084-M16C12980029 260084-M16C12980005 260084-M16C12980013 260084-M16C12980023 260084-M16C12980012 260084-M16C12980009 260084-M16C12980015 260084-M16C12980016 260084-M16C12980018 260084-M16C12980030 260084-M16C12980034 260084-M16C12980033 260084-M16C12980003 260084-M16C12980010 260084-M16C12980014 260084-M16C12980039 260084-M16C12980021 260084-M16C12980004 260084-M16C12980019 260084-M16C12980026 260084-M16C12980040 260084-M16C12980025 260760-M17100750074 260760-M17100750072 260760-M17100750039 260760-M17100750075 260760-M17100750007 260760-M17100750008 260760-M17100750009 260760-M17100750010 260760-M17100750037 260760-M17100750038 260760-M17100750043 260760-M17100750081 260760-M17100750048 260760-M17100750049 260760-M17100750050 260760-M17100750082 260760-M17100750085 260760-M17100750092 260760-M17100750011 260760-M17100750015 260760-M17100750071 260760-M17100750014 260760-M17100750047 260760-M17100750058 260760-M17100750059 260760-M17100750056 260760-M17100750060 260760-M17100750021 260760-M17100750093 260760-M17100750098 260760-M17100750099 260760-M17100750100 260760-M17100750013 260760-M17100750018 260760-M17100750019 260760-M17100750023 260760-M17100750057 260760-M17100750029 260760-M17100750040 260760-M17100750006 260760-M17100750020 260760-M17100750036 260760-M17100750046 260760-M17100750066 260760-M17100750067 260760-M17100750068 260760-M17100750069 260760-M17100750076 260760-M17100750030 260760-M17100750022 260760-M17100750089 260760-M17100750025 260760-M17100750065 260760-M17100750073 260760-M17100750001 260760-M17100750002 260760-M17100750005 260760-M17100750031 260760-M17100750064 260760-M17100750032 260760-M17100750024 260760-M17100750041 260760-M17100750042 260760-M17100750063 260760-M17100750077 260760-M17100750078 260760-M17100750079 260760-M17100750034 260760-M17100750080 260760-M17100750062 260760-M17100750045 260760-M17100750086 260760-M17100750096 260760-M17100750097 260760-M17100750003 260760-M17100750004 260760-M17100750033 260760-M17100750044 260760-M17100750061 260760-M17100750012 260760-M17100750052 260760-M17100750054 260760-M17100750055 260760-M17100750070 260760-M17100750083 260760-M17100750087 260760-M17100750088 260760-M17100750051 260760-M17100750090 260760-M17100750035 260760-M17100750053 260760-M17100750084 260760-M17100750091 260760-M17100750094 260760-M17100750095 260760-M17100750016 260760-M17100750017 260760-M17100750026 260760-M17100750027 260760-M17100750028 260760-M17106910037 260760-M17106910024 260760-M17106910023 260760-M17106910014 260760-M17106910013 260760-M17106910002 260727-M17106920122 260760-M17106910039 260727-M17106920120 260727-M17106920110 260727-M17106920143 260760-M17106900004 260084-M17106930016 260760-M17106900021 260760-M17106900030 260084-M17106930002 260727-M17106920109 260727-M17106920001 260727-M17106920028 260727-M17106920002 260727-M17106920003 260727-M17106920004 260727-M17106920008 260727-M17106920014 260727-M17106920018 260727-M17106920019 260727-M17106920027 260760-M17106900011 260727-M17106920090 260727-M17106920049 260727-M17106920075 260727-M17106920136 260727-M17106920146 260760-M17106910003 260760-M17106910004 260760-M17106910012 260760-M17106910022 260760-M17106910030 260760-M17106910036 260760-M17106900006 260760-M17106900009 260760-M17106900018 260760-M17106910038 260760-M17106910040 260727-M17106920080 261023-M17106940004 260760-M17106900023 260760-M17106900028 260084-M17106930003 260084-M17106930018 260084-M17106930019 260727-M17106920006 260727-M17106920015 260727-M17106920025 260727-M17106920030 260727-M17106920047 260727-M17106920050 260727-M17106920057 260727-M17106920060 260760-M17106900013 260727-M17106920029 260760-M17106910033 260727-M17106920078 260727-M17106920036 260727-M17106920046 260727-M17106920056 260727-M17106920071 260727-M17106920072 260727-M17106920073 260727-M17106920086 260727-M17106920103 260727-M17106920114 260727-M17106920117 260727-M17106920131 260727-M17106920139 260727-M17106920149 260760-M17106910008 260760-M17106910010 260760-M17106910016 260760-M17106910019 260760-M17106910020 260760-M17106910026 260760-M17106910028 260727-M17106920129 260760-M17106910035 260760-M17106900001 260760-M17106900014 260760-M17106900022 260760-M17106900024 260760-M17106900025 260727-M17106920024 260727-M17106920023 260727-M17106920022 260727-M17106920021 260727-M17106920079 260727-M17106920096 260727-M17106920105 260727-M17106920113 260727-M17106920115 260727-M17106920123 260727-M17106920125 260727-M17106920137 260727-M17106920138 260727-M17106920141 260760-M17106910006 260760-M17106910009 260760-M17106910018 260727-M17106920074 260760-M17106910032 260760-M17106900007 260760-M17106900012 260760-M17106900015 260760-M17106900026 260084-M17106930006 260084-M17106930010 260084-M17106930012 260084-M17106930014 260727-M17106920007 260727-M17106920009 260727-M17106920011 260727-M17106920012 260727-M17106920013 260760-M17106910034 260727-M17106920112 260727-M17106920101 260727-M17106920100 260760-M17106910011 260760-M17106910021 261023-M17106940005 261023-M17106940007 261023-M17106940008 261023-M17106940009 260760-M17106900008 260760-M17106900016 260760-M17106900019 260760-M17106900020 260760-M17106900027 260760-M17106900029 260084-M17106930005 260760-M17106910007 260084-M17106930007 260727-M17106920066 260727-M17106920095 260727-M17106920106 260727-M17106920118 260727-M17106920124 260727-M17106920127 260727-M17106920102 260727-M17106920132 260727-M17106920140 260727-M17106920142 260760-M17106910015 260760-M17106910025 260760-M17106910031 260084-M17106930011 260760-M17106900002 260727-M17106920148 260727-M17106920144 260727-M17106920010 260727-M17106920017 260727-M17106920020 260727-M17106920031 260727-M17106920032 260727-M17106920033 260727-M17106920041 260727-M17106920051 260727-M17106920052 260727-M17106920053 260727-M17106920061 260727-M17106920062 260727-M17106920063 260727-M17106920147 260727-M17106920064 260727-M17106920077 260727-M17106920081 260727-M17106920082 260727-M17106920083 260727-M17106920084 260727-M17106920092 260727-M17106920093 260727-M17106920094 260727-M17106920098 260727-M17106920104 260727-M17106920107 260727-M17106920108 260727-M17106920134 260727-M17106920070 260760-M17106900005 260727-M17106920128 260727-M17106920037 260084-M17106930017 260727-M17106920005 260727-M17106920016 260727-M17106920035 260727-M17106920045 260727-M17106920055 260727-M17106920034 260727-M17106920085 260727-M17106920111 260727-M17106920119 260727-M17106920121 260727-M17106920130 260727-M17106920150 260084-M17106930015 260760-M17106910005 261023-M17106940010 260084-M17106930008 260084-M17106930009 260084-M17106930013 260084-M17106930020 260727-M17106920026 260727-M17106920040 260727-M17106920065 260727-M17106920087 260727-M17106920088 260727-M17106920089 260727-M17106920097 260727-M17106920099 261023-M17106940006 260084-M17106930004 260727-M17106920076 260760-M17106900017 260727-M17106920038 260727-M17106920039 260727-M17106920042 260727-M17106920043 260727-M17106920044 260084-M17106930001 260727-M17106920054 260727-M17106920058 260727-M17106920059 260727-M17106920067 260727-M17106920068 260727-M17106920069 260727-M17106920091 260727-M17106920048 261023-M17106940002 260760-M17106900010 260760-M17106900003 261023-M17106940003 261023-M17106940001 260727-M17106920116 260760-M17106910027 260760-M17106910029 260760-M17106910001 260727-M17106920145 260727-M17106920135 260727-M17106920133 260727-M17106920126 260760-M17106910017 260760-M17301290009 260760-M17301290012 260760-M17301290014 260760-M17301290036 260760-M17301290039 260760-M17301290052 260760-M17301290066 260760-M17301290073 260760-M17301290015 260760-M17301290070 260760-M17301290057 260760-M17301290064 260760-M17301290062 260760-M17301290035 260760-M17301290034 260760-M17301290032 260760-M17301290027 260760-M17301290043 260760-M17301290041 260760-M17301290040 260760-M17208320018 260760-M17301290065 260760-M17301290069 260760-M17301290037 260760-M17301290017 260760-M17208320008 260760-M17301290075 260760-M17301290072 260760-M17301290068 260760-M17301290067 260760-M17301290051 260760-M17301290049 260760-M17301290038 260760-M17301290029 260760-M17301290026 260760-M17208320022 260760-M17301290025 260760-M17301290022 260760-M17301290013 260760-M17301290011 260760-M17301290010 260760-M17208320025 260760-M17208320020 260760-M17301290074 260760-M17301290058 260760-M17301290053 260760-M17301290050 260760-M17301290024 260760-M17208320023 260760-M17301290018 260760-M17208320010 260760-M17301290023 260760-M17301290021 260760-M17301290020 260760-M17301290008 260760-M17301290003 260760-M17208320021 260760-M17208320014 260760-M17301290059 260760-M17301290056 260760-M17301290055 260760-M17301290028 260760-M17301290054 260760-M17301290016 260760-M17301290006 260760-M17301290005 260760-M17301290004 260760-M17301290002 260760-M17208320024 260760-M17208320013 260760-M17208320009 260760-M17208320004 260760-M17208320015 260760-M17301290019 260760-M17301290047 260760-M17301290001 260760-M17301290071 260760-M17208320007 260760-M17301290007 260760-M17208320001 260760-M17208320019 260760-M17301290048 260760-M17208320012 260760-M17208320003 260760-M17301290063 260760-M17301290061 260760-M17301290060 260760-M17301290046 260760-M17208320016 260760-M17301290044 260760-M17301290042 260760-M17301290033 260760-M17301290031 260760-M17301290030 260760-M17208320002 260760-M17208320017 260760-M17208320011 260760-M17208320006 260760-M17208320005 260760-M17301290045 260760-M17307370043 260760-M17307370027 260760-M17307370029 260760-M17307370047 260760-M17307400046 260760-M17307370055 260727-M17307430130 260760-M17307400075 260760-M17307400044 260760-M17307400043 260727-M17307430106 260727-M17307430089 260727-M17307430075 260760-M17307370051 260727-M17307430066 260727-M17307430057 260727-M17307430045 260727-M17307430029 260760-M17307400041 260760-M17307400036 260760-M17307400032 260760-M17307400026 260727-M17307430063 260760-M17307400042 260760-M17307370018 260760-M17307370023 260760-M17307400004 260760-M17307400005 260760-M17307400030 260760-M17307400040 260760-M17307400049 260760-M17307400057 260760-M17307400065 260727-M17307430011 260727-M17307430017 260727-M17307430034 260727-M17307430039 260727-M17307430042 260727-M17307430048 260727-M17307430054 260727-M17307430059 260727-M17307430061 260727-M17307430074 260727-M17307430081 260727-M17307430087 260727-M17307430100 260727-M17307430110 260727-M17307430111 260727-M17307430112 260727-M17307430126 260727-M17307430143 260727-M17307430144 260760-M17307370001 260760-M17307370005 260727-M17307430131 260727-M17307430060 260727-M17307430145 260760-M17307370030 260727-M17307430150 260760-M17307370044 260760-M17307370039 260760-M17307370037 260760-M17307370033 260760-M17307370024 260760-M17307370006 260760-M17307370049 260760-M17307370002 260727-M17307430129 260727-M17307430125 260727-M17307430114 260727-M17307430113 260727-M17307430107 260727-M17307430104 260727-M17307430147 260760-M17307370050 260760-M17307370063 260760-M17307370067 260727-M17307430027 260727-M17307430021 260727-M17307430020 260727-M17307430016 260727-M17307430013 260727-M17307430009 260760-M17307400070 260760-M17307400056 260760-M17307400054 260760-M17307400053 260760-M17307400052 260760-M17307400051 260760-M17307400047 260760-M17307400037 260760-M17307370069 260727-M17307430103 260727-M17307430146 260727-M17307430085 260727-M17307430065 260760-M17307400020 260760-M17307400019 260760-M17307400018 260760-M17307400010 260760-M17307370075 260760-M17307370071 260760-M17307400028 260760-M17307370060 260760-M17307370053 260760-M17307370048 260760-M17307400003 260760-M17307370028 260760-M17307370016 260760-M17307370012 260760-M17307370057 260760-M17307400029 260760-M17307400038 260760-M17307400039 260727-M17307430046 260727-M17307430043 260727-M17307430025 260727-M17307430018 260727-M17307430012 260727-M17307430008 260727-M17307430006 260727-M17307430003 260727-M17307430002 260760-M17307400066 260760-M17307400064 260760-M17307400063 260760-M17307400062 260760-M17307400061 260760-M17307400048 260727-M17307430080 260760-M17307400002 260760-M17307370038 260760-M17307370070 260727-M17307430019 260727-M17307430014 260727-M17307430004 260727-M17307430101 260727-M17307430095 260727-M17307430082 260727-M17307430035 260727-M17307430067 260727-M17307430053 260727-M17307430047 260727-M17307430010 260727-M17307430007 260727-M17307430001 260760-M17307400067 260727-M17307430056 260727-M17307430055 260727-M17307430120 260727-M17307430124 260727-M17307430119 260727-M17307430118 260727-M17307430108 260727-M17307430102 260760-M17307370036 260760-M17307370032 260760-M17307370025 260760-M17307370021 260760-M17307370017 260760-M17307370013 260760-M17307370009 260760-M17307370007 260760-M17307370003 260727-M17307430139 260727-M17307430135 260760-M17307400055 260727-M17307430137 260760-M17307400027 260760-M17307400009 260727-M17307430077 260727-M17307430071 260727-M17307430070 260727-M17307430069 260727-M17307430064 260727-M17307430051 260727-M17307430084 260727-M17307430050 260727-M17307430031 260727-M17307430030 260727-M17307430028 260727-M17307430026 260727-M17307430023 260727-M17307430022 260727-M17307430037 260727-M17307430092 260727-M17307430093 260727-M17307430096 260760-M17307400008 260760-M17307370072 260760-M17307370065 260760-M17307370061 260760-M17307370040 260760-M17307370035 260760-M17307370031 260760-M17307370020 260760-M17307370019 260760-M17307370014 260727-M17307430138 260727-M17307430132 260727-M17307430127 260727-M17307430123 260727-M17307430098 260760-M17307400017 260760-M17307400001 260727-M17307430140 260727-M17307430142 260727-M17307430086 260727-M17307430083 260727-M17307430068 260727-M17307430062 260727-M17307430058 260727-M17307430052 260727-M17307430088 260727-M17307430041 260727-M17307430038 260727-M17307430036 260727-M17307430033 260727-M17307430032 260727-M17307430024 260727-M17307430015 260727-M17307430040 260727-M17307430090 260727-M17307430091 260727-M17307430097 260760-M17307370068 260760-M17307370059 260760-M17307370054 260727-M17307430044 260760-M17307370015 260760-M17307370011 260760-M17307370008 260727-M17307430149 260727-M17307430148 260727-M17307430134 260727-M17307430133 260727-M17307430116 260727-M17307430115 260727-M17307430109 260727-M17307430105 260727-M17307430005 260727-M17307430141 260760-M17307400073 260760-M17307400013 260760-M17307400012 260760-M17307400011 260760-M17307400007 260760-M17307400006 260760-M17307370074 260760-M17307400014 260760-M17307370066 260760-M17307370046 260760-M17307370045 260760-M17307370041 260760-M17307370056 260760-M17307370052 260760-M17307370010 260760-M17307370062 260760-M17307400016 260760-M17307400021 260760-M17307400022 260760-M17307400072 260760-M17307400071 260760-M17307400069 260760-M17307400068 260760-M17307400060 260760-M17307400059 260760-M17307400050 260760-M17307400045 260760-M17307400035 260760-M17307400034 260760-M17307400033 260760-M17307400031 260760-M17307400025 260760-M17307400024 260760-M17307400023 260760-M17307400074 260727-M17307430049 260727-M17307430079 260727-M17307430128 260760-M17307400058 260760-M17307400015 260760-M17307370064 260760-M17307370073 260727-M17307430121 260727-M17307430117 260727-M17307430099 260727-M17307430094 260727-M17307430078 260727-M17307430076 260727-M17307430073 260727-M17307430072 260727-M17307430136 260760-M17307370004 260760-M17307370022 260760-M17307370026 260760-M17307370034 260760-M17307370042 260727-M17307430122 260760-M17307370058 260760-M17401120016 260760-M17401120012 260760-M17401120038 260760-M17401120022 260760-M17401120009 260760-M17401120034 260760-M17401120095 260760-M17401120026 260760-M17401120002 260760-M17401120006 260760-M17401120013 260760-M17401120017 260760-M17401120023 260760-M17401120027 260760-M17401120041 260760-M17401120044 260760-M17401120049 260760-M17401120053 260760-M17401120057 260760-M17401120072 260760-M17401120076 260760-M17401120080 260760-M17401120082 260760-M17401120086 260760-M17401120092 260760-M17401120096 260760-M17401120032 260760-M17401120100 260760-M17401120079 260760-M17401120075 260760-M17401120068 260760-M17401120084 260760-M17401120089 260760-M17401120090 260760-M17401120091 260760-M17401120094 260760-M17401120099 260760-M17401120005 260760-M17401120010 260760-M17401120011 260760-M17401120036 260760-M17401120014 260760-M17401120020 260760-M17401120021 260760-M17401120029 260760-M17401120043 260760-M17401120047 260760-M17401120050 260760-M17401120051 260760-M17401120059 260760-M17401120064 260760-M17401120019 260760-M17401120081 260760-M17401120048 260760-M17401120055 260760-M17401120008 260760-M17401120004 260760-M17401120001 260760-M17401120098 260760-M17401120088 260760-M17401120065 260760-M17401120037 260760-M17401120033 260760-M17401120007 260760-M17401120003 260760-M17401120097 260760-M17401120093 260760-M17401120087 260760-M17401120083 260760-M17401120069 260760-M17401120061 260760-M17401120060 260760-M17401120056 260760-M17401120052 260760-M17401120030 260760-M17401120071 260760-M17401120031 260760-M17401120039 260760-M17401120046 260760-M17401120042 260760-M17401120040 260760-M17401120025 260760-M17401120070 260760-M17401120015 260760-M17401120085 260760-M17401120077 260760-M17401120073 260760-M17401120063 260760-M17401120058 260760-M17401120035 260760-M17401120028 260760-M17401120024 260760-M17401120018 260760-M17401120078 260760-M17401120074 260760-M17401120066 260760-M17401120062 260760-M17401120045 260760-M17401120054 260760-M17401120067 261023-M17405610016 261023-M17405610004 261023-M17405610009 261023-M17405610014 261023-M17405610020 261023-M17405610011 261023-M17405610019 261023-M17405610012 261023-M17405610010 261023-M17405610005 261023-M17405610002 261023-M17405610001 261023-M17405610006 261023-M17405610015 261023-M17405610003 261023-M17405610007 261023-M17405610008 261023-M17405610013 261023-M17405610017 261023-M17405610018 260084-M17506690014 260084-M17506690025 260084-M17506690013 260084-M17506690028 260084-M17506690017 260084-M17506690012 260084-M17506690011 260084-M17506690005 260084-M17506690006 260084-M17506690022 260084-M17506690021 260084-M17506690016 260084-M17506690010 260084-M17506690009 260084-M17506690004 260084-M17506690003 260084-M17506690019 260084-M17506690018 260084-M17506690027 260084-M17506690002 260084-M17506690001 260084-M17506690030 260084-M17506690026 260084-M17506690020 260084-M17506690015 260084-M17506690007 260084-M17506690029 260084-M17506690024 260084-M17506690023 260084-M17506690008 260084-M17608370003 260084-M17608370008 260084-M17608370023 261023-M17608380012 260084-M17608370004 260084-M17608370005 260084-M17608370020 260084-M17608370026 261023-M17608380006 260084-M17608370029 260084-M17608370027 260084-M17608370021 260084-M17608370016 261023-M17608380014 260084-M17608370015 260084-M17608370014 260084-M17608370009 260084-M17608370007 260084-M17608370001 260084-M17608370018 260084-M17608370017 260084-M17608370002 261023-M17608380004 260084-M17608370013 261023-M17608380007 261023-M17608380008 261023-M17608380010 260084-M17608370022 261023-M17608380001 261023-M17608380005 261023-M17608380011 261023-M17608380013 261023-M17608380015 260084-M17608370010 260084-M17608370012 260084-M17608370028 260084-M17608370011 260084-M17608370019 260084-M17608370024 260084-M17608370025 261023-M17608380002 260084-M17608370006 261023-M17608380003 260084-M17608370030 261023-M17608380009 260760-M17608390024 260760-M17608390038 260760-M17608390030 260760-M17608390011 260760-M17608390004 260760-M17608390092 260760-M17608390083 260760-M17608390078 260760-M17608390070 260760-M17608390061 260760-M17608390055 260760-M17608390053 260760-M17608390031 260760-M17608390025 260760-M17608390023 260760-M17608390002 260760-M17608390098 260760-M17608390090 260760-M17608390082 260760-M17608390072 260760-M17608390064 260760-M17608390041 260760-M17608390060 260760-M17608390068 260760-M17608390076 260760-M17608390043 260760-M17608390028 260760-M17608390020 260760-M17608390015 260760-M17608390013 260760-M17608390008 260760-M17608390087 260760-M17608390079 260760-M17608390077 260760-M17608390056 260760-M17608390066 260760-M17608390048 260760-M17608390040 260760-M17608390036 260760-M17608390018 260760-M17608390010 260760-M17608390001 260760-M17608390094 260760-M17608390089 260760-M17608390085 260760-M17608390054 260760-M17608390034 260760-M17608390026 260760-M17608390005 260760-M17608390044 260760-M17608390042 260760-M17608390032 260760-M17608390029 260760-M17608390027 260760-M17608390014 260760-M17608390009 260760-M17608390007 260760-M17608390095 260760-M17608390057 260760-M17608390093 260760-M17608390075 260760-M17608390069 260760-M17608390067 260760-M17608390052 260760-M17608390046 260760-M17608390039 260760-M17608390037 260760-M17608390022 260760-M17608390016 260760-M17608390086 260760-M17608390059 260760-M17608390062 260760-M17608390071 260760-M17608390003 260760-M17608390099 260760-M17608390097 260760-M17608390088 260760-M17608390081 260760-M17608390080 260760-M17608390073 260760-M17608390065 260760-M17608390063 260760-M17608390051 260760-M17608390049 260760-M17608390047 260760-M17608390035 260760-M17608390033 260760-M17608390021 260760-M17608390019 260760-M17608390017 260760-M17608390006 260760-M17608390100 260760-M17608390091 260760-M17608390084 260760-M17608390045 260760-M17608390050 260760-M17608390012 260760-M17608390074 260760-M17608390096 260760-M17608390058 261023-M17803960004 261023-M17803960001 261023-M17803960002 261023-M17803960003 261023-M17803960005 261023-M17809200002 261023-M17809200003 261023-M17809200004 261023-M17809200001 261023-M17906040001 261023-M17907720002 261023-M17907720003 261023-M17907720001 260760-M17912220056 260760-M17912220057 260760-M17912220059 260760-M17912220063 260760-M17912220064 260760-M17912220075 260760-M17912220080 260760-M17912220096 260760-M17912220097 260760-M17912220099 260084-M17912210019 260084-M17912210

Affected States

ALL

Report Date

January 28, 2026

Source Agency

FDA - Medical Devices

Recall Status

ACTIVE

Related Recalls

MEDIUM

Feb 9, 2026

Taro Pharmaceuticals Withdraws Diclofenac Sodium Gel Over Viscosity Issues

Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.

CETRORELIX ACETATE

Defective delivery

HIGH

Feb 5, 2026

Fresenius Kabi Compounding Recalls Acyclovir Sodium Injection Due to Sterility Risks

Fresenius Kabi Compounding recalled 1,057 bags of Acyclovir Sodium Injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers should cease use immediately and contact the manufacturer for guidance.

Fresenius Kabi Compounding

Lack of

HIGH

Feb 5, 2026

Fresenius Kabi Vancomycin Injection Recalled Over Sterility Concerns

Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.

Fresenius Kabi Compounding

Lack of

HIGH

Feb 5, 2026

Fresenius Kabi Compounding Issues Recall of Vancomycin Injection

Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.

Fresenius Kabi Compounding

Lack of

HIGH

Feb 5, 2026

Fresenius Kabi Compounding Recalls Ketamine Injection for Sterility Risk

Fresenius Kabi Compounding recalled 1,410 bags of ketamine HCl injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers and consumers must stop using this product immediately.

Fresenius Kabi Compounding

Lack of

HIGH

Feb 5, 2026

Fresenius Kabi Compounding Recalls Thiamine Injection Over Sterility Risk

Fresenius Kabi Compounding recalled 10,548 bags of thiamine HCl injection on February 5, 2026. The recall follows a lack of assurance of sterility, posing a high health risk. Affected products include several lots expiring between February and May 2026.

Fresenius Kabi Compounding

Lack of

HIGH

Feb 2, 2026

Pro Numb Tattoo Numbing Spray Recalled Due to cGMP Violations

Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.

PRO NUMB SENSITIVE SKIN

cGMP deviations

HIGH

Feb 2, 2026

Pro Numb Tattoo Numbing Spray Recalled Due to cGMP Deviations

Pro Numb Tattoo Numbing Spray was recalled due to cGMP deviations. The recall affects products distributed nationwide in the USA. Consumers should stop using the spray immediately and contact Pro Numb Tattoo Numbing Spray LLC for guidance.

PRO NUMB

cGMP deviations