fda regulated Recalls

1,320 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA 40KWFXPLUS.002 Mobile X-ray System Recalled in 2025 (8 Units)

Sedecal SA recalled 8 mobile X-ray units in the United States after notifying consignees that the equipment is not water-resistant and must be cleaned strictly per the manual. The notice warns that improper cleaning could have consequences described in the manual. Healthcare providers and patients should stop using the devices immediately and contact Sedecal SA or their healthcare provider for the

Sedecal
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal Easy Moving Plus Mobile X-ray System Recalled for Cleaning Not Water-Resistant Risk (8 Units

Sedecal recalled 8 units of the Easy Moving Plus mobile X-ray system distributed in California, Illinois and New Jersey. The devices are not water-resistant and cleaning must follow the manual to avoid the consequences of improper cleaning. Stop using the device and contact Sedecal SA or your healthcare provider for instructions.

Sedecal
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA Recalled 5 SM-40HF-B-D-C Mobile X-ray Systems for Cleaning Warning (2025)

Sedecal SA recalled 5 SM-40HF-B-D-C 40KW 55G Mobile X-ray systems distributed in the US (CA, IL, NJ) after warning that the equipment is not water-resistant and must be cleaned strictly per the manual. The notice outlines the possible consequences of improper cleaning. Healthcare facilities should stop using the devices immediately and contact Sedecal SA for instructions.

Sedecal SA
Sedecal sent
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Food & Beverages
HIGH
FDA FOOD

Primo No. 1 in Produce Recalls 89 Boxes of Cucumber Sliced in 2025 Over Salmonella Contamination

Primo No. 1 in Produce recalled 89 boxes of sliced cucumbers after a Salmonella contamination was confirmed. The product is Cucumber Sliced 8oz 8ct/4#AV in cardboard boxes. It was distributed to Virginia, New York, Pennsylvania and New Jersey. Consumers should not eat this product and should contact Primo No. 1 in Produce for refund or replacement.

Primo No. 1 in Produce
Product contaminated
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Food & Beverages
HIGH
FDA FOOD

PRIMO NO. 1 IN PRODUCE Recalled 89 Boxes of Sliced Cucumber for Salmonella Contamination (2025)

PRIMO NO. 1 IN PRODUCE recalled 89 boxes of sliced cucumber packaged in 2/10-lb boxes distributed to Virginia, New York, Pennsylvania and New Jersey after Salmonella contamination. The recall is active and classified as high risk. Consumers should not eat the product and should contact PRIMO NO. 1 IN PRODUCE for refund or replacement.

PRIMO NO. 1 IN PRODUCE
Product contaminated
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Food & Beverages
HIGH
FDA FOOD

PRIMO NO. 1 IN PRODUCE Cucumber Tray Recall Affects 89 Boxes in 2025

PRIMO NO. 1 IN PRODUCE recalls 89 boxes of Vegetable Tray Cucumbers distributed to Virginia, New York, Pennsylvania and New Jersey due to Salmonella contamination. Consumers should not consume the product. Contact PRIMO NO. 1 IN PRODUCE, INC for refund or replacement information via email, fax, letter, press release, telephone or visit.

PRIMO NO. 1 IN PRODUCE
Product contaminated
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Food & Beverages
HIGH
FDA FOOD

PRIMO NO. 1 IN PRODUCE Cucumber Peeled Sliced 2/5lb Boxes Recalled for Salmonella Contamination (202

PRIMO NO. 1 IN PRODUCE recalled 89 boxes of peeled-sliced cucumbers distributed to Virginia, New York, Pennsylvania and New Jersey after Salmonella contamination was detected. The recall was issued on May 20, 2025. Consumers should not eat the product and should contact PRIMO NO. 1 IN PRODUCE, INC for refund or replacement.

PRIMO NO. 1 IN PRODUCE
Product contaminated
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Food & Beverages
HIGH
FDA FOOD

Chefs Warehouse Recalls 5 lb Diced Cucumber for Salmonella Contamination (2025)

Chefs Warehouse recalled 5 lb diced cucumber distributed to Maryland, Delaware and Virginia after FDA confirmation of Salmonella contamination. The product is a 5 lb bag labeled 5# Lot#B0515911. Consumers should not consume the recalled cucumber and should contact Chefs Warehouse for refund or replacement.

Chefs Warehouse
Product is
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Food & Beverages
HIGH
FDA FOOD

Chefs Warehouse Recalls 15 Lbs of Cucumber Slices for Salmonella Contamination (2025)

Chefs Warehouse recalls 15 pounds of cucumber slices after Salmonella contamination was detected. The recall covers 10-pound and 5-pound packages labeled 5# Lot#B0515465 and 5# Lot#B0515867 distributed to Maryland, Delaware and Virginia. Consumers should not consume the recalled cucumbers and should contact Chefs Warehouse for refund or replacement.

Chefs Warehouse
Product is
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Health & Personal Care
HIGH
FDA DEVICE

Medtronic MiniMed Recalls 1,440 Simplera Sensor Units Over Label Adhesion Risk (2025)

Medtronic MiniMed recalled 1,440 Simplera Sensor units distributed outside the United States after a device cap label may not adhere, risking sterility. The defect could increase infection risk. Patients and healthcare providers should stop using the device and follow recall instructions provided by Medtronic MiniMed or their healthcare provider.

Medtronic MiniMed
The device
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Food & Beverages
HIGH
FDA FOOD

Turkana Food Floria Dried Apricots Recalled in 352-Case High-Hazard Alert (2025)

Turkana Food Inc. recalled 352 cases of Floria Dried Apricots, 200-gram packages, distributed to retailers in 19 states. The recall was issued on April 29, 2025. The product contains undeclared sulfites. Consumers should not eat it and should contact Turkana Food Inc. for refund or replacement via email.

Turkana Food
Product contains
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Health & Personal Care
HIGH
FDA DRUG

World Perfumes Inc. Recalled Iodo Blanco Iodides First Aid Antiseptic Over Leaking Containers (2025)

World Perfumes Inc. recalled 3,900 bottles of Iodo Blanco Iodides First Aid Antiseptic in Florida after broken or leaking containers were reported. The recall covers iodine 2% antiseptic distributed by Essential Products. Consumers should stop use immediately and contact World Perfumes or a healthcare provider for guidance.

World Perfumes
Defective Container:
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Health & Personal Care
HIGH
FDA DEVICE

MEDITECH Expanse Lab Calculator Module Recalled for Input Error Risk in 2025

MEDITECH released an active recall for the Expanse Laboratory calculator/data processing module. The recall covers 148 units distributed worldwide, including the US, UK, Canada, Ireland and the British Virgin Islands. The hazard concerns simultaneous multi-key inputs potentially removing data from the first field in screens or questionnaires.

Medical Information Technology
Entering multiple
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Health & Personal Care
HIGH
FDA DEVICE

CorNeat Vision EverPatch 1036295 Recall for Labeling Update in 2024

CorNeat Vision recalled EverPatch surgical matrix (REF 1036295) in a worldwide distribution that includes 50 states and several countries. The recall addresses retroactive labeling corrections to include prevention and management of would dehiscence. Healthcare providers and patients should stop using the device and follow the manufacturer's recall instructions.

CorNeat Vision
Retroactive; Due
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Health & Personal Care
HIGH
FDA DEVICE

Omnia Medical TiBrid Stand Alone Fusion Device Recalled for Field Instrument Failure

Omnia Medical recalled 15 units of the TiBrid Stand Alone Intervertebral Body Fusion Device SA Angled Punch Awl. The recall covers models 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5 with UDI 00843511113056 and 00843511122287/22294. The hazard is failure of fusion system instruments in the field. Consumers should stop use and follow recall instructions.

Omnia Medical
Failure of
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Health & Personal Care
HIGH
FDA DEVICE

Surepulse Medical Issues Recall for Newborn Heart Rate Monitor Component

Surepulse Medical recalled the VS Cap Small component of its newborn heart rate monitor on January 20, 2023. The recall stems from incorrect sizing information provided on the product label. This defect poses a significant risk to patient safety.

SUREPULSE MEDICAL
Retroactively reported;
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Health & Personal Care
HIGH
FDA DEVICE

Surepulse Heart Rate Monitor Cap Recalled for Sizing Error

Surepulse Medical recalled the Extra Large VS Cap component of its newborn heart rate monitor on January 20, 2023. The recall followed reports of incorrect sizing information that could impact device use. This recall affects distribution in the U.S., the U.K., the Netherlands, and the United Arab Emirates.

SUREPULSE MEDICAL
Retroactively reported;
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Health & Personal Care
HIGH
FDA DEVICE

Foundation Medicine FoundationOne CDx Recalled for Missing Companion Diagnostic Claims Page

Foundation Medicine recalled 59 units of FoundationOne CDx (F1CDx), RAL-0003 version 31.0 after reports indicated the companion diagnostic Claims Page was omitted. This oversight could impact patient care and healthcare provider decisions concerning diagnosis and treatment. Users should stop using the device and contact Foundation Medicine or their healthcare provider for further instructions.

Foundation Medicine
Reports were
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Health & Personal Care
HIGH
FDA DEVICE

Foundation Medicine FoundationOne Liquid CDx Recall 2022 Reminds Clinicians to Check CDx Pages (18 U

Foundation Medicine issued a recall affecting 18 FoundationOne Liquid CDx tests, including 17 in the United States and 1 overseas. The defect is the absence of the companion diagnostic CDx Claims Page in reports. Amended claims pages were distributed within seven days. Stop use immediately and follow manufacturer instructions.

Foundation Medicine
Reports were
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Tag Statistics

Total Recalls
1,320

Related Tags

electrical hazardelectronicimmediate actionstop use immediatelyreturn for refundreplacement availablecpsc regulatednhtsa regulatedrepair availablebattery poweredpoisoning riskkitchen