cpsc regulated Recalls

1,716 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DEVICE

VANTIVE US HEALTHCARE Recalls Dialyzer Due to Dislodgement Hazard

VANTIVE US HEALTHCARE recalled 87,436 Prismaflex ST100 Dialyzers on January 6, 2026. The recall follows reports of potential dislodgement of the deaeration chamber from the control unit. Healthcare providers and patients must stop using the device immediately.

VANTIVE US HEALTHCARE
There is
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Health & Personal Care
HIGH
FDA DEVICE

VANTIVE US Healthcare Recalls Dialyzer Over Dislodgement Risk

VANTIVE US Healthcare recalled 137,576 Prismaflex M150 Sets on January 6, 2026. The recall addresses a risk of dislodgement of the deaeration chamber from the control unit. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

VANTIVE US HEALTHCARE
There is
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Health & Personal Care
HIGH
FDA DEVICE

VANTIVE US HEALTHCARE Recalls Dialyzer Due to Dislodgement Hazard

VANTIVE US HEALTHCARE recalled 13,760 Prismaflex TPE2000 Sets on January 6, 2026, due to a potential dislodgement hazard. The recall affects the deaeration chamber of the Prismaflex Control Unit. Healthcare providers and patients must stop using the device immediately.

VANTIVE US HEALTHCARE
There is
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Health & Personal Care
HIGH
FDA DEVICE

Straumann USA Recalls Impression Caps Over Mix-Up Hazard

Straumann USA recalled 561 units of its Impression Post Closed Tray on January 6, 2026. The recall occurred due to a mix-up where impression caps were mistakenly packaged in magenta instead of the intended brown. Healthcare providers and patients must stop using the device immediately.

Straumann USA
The mix
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Health & Personal Care
HIGH
FDA DEVICE

VANTIVE US Healthcare Recalls Dialyzer Over Dislodgement Risk

VANTIVE US Healthcare recalled 230,596 units of the PRIMSAFLEX M100 Set on January 6, 2026. The recall follows a risk of dislodgement of the deaeration chamber from the control unit. Healthcare providers and patients must stop using the device immediately.

VANTIVE US HEALTHCARE
There is
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Sterile Saline Wound Wash Over Sterility Concerns

Medline Industries has recalled 3,578,805 units of its sterile saline wound wash due to potential sterility assurance issues. The recall, effective January 5, 2026, affects products distributed worldwide, including in the U.S. Consumers should stop using the product immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Encore Medical Recalls EMPOWR Acetabular System Over Packaging Errors

Encore Medical, LP recalled 49 units of the EMPOWR Acetabular System on January 5, 2026. Packaging errors may cause surgical delays, potentially affecting patient safety. Healthcare providers should stop using these devices immediately.

Encore Medical, LP
942-01-40G acetabular
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Saline Wound Wash Over Sterility Concerns

Medline Industries recalled 104,608 units of sterile saline wound wash on January 5, 2026. The product may not have met the required sterility assurance level. Consumers should stop using this product immediately and follow recall instructions.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Convenience Kits Over Sterility Concerns

Medline Industries recalled 10,550 wound care kits on January 5, 2026, due to potential sterility issues. The recall affects several model numbers, including DYKM1361A and DYKM2013. Consumers should stop using the kits immediately and follow the manufacturer's instructions.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Medline Nail Kit Recalled Over Sterility Concerns

Medline Industries recalled 1,640 units of its Nail Kit, Model POD14214, on January 5, 2026. The recall stems from concerns that the sterile saline wound wash may not meet required sterility standards. Patients and healthcare providers must stop using the product immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

AVID Medical Recalls Transport Bag Kit Over Sterility Risk

AVID Medical recalled 1,500 units of the TRANSPORT BAG KIT on January 2, 2026. A seal issue with the Tyvek bag may compromise the sterility of the kit. The recall affects healthcare providers and patients in New Jersey.

AVID Medical
Tyvek bag
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Health & Personal Care
HIGH
FDA DEVICE

Alphatec Spine Recalls Surgical Instruments Over Connection Issue

Alphatec Spine recalled 7 units of Lateral Navigation Disc Prep Instruments on January 2, 2026, due to a design flaw. The incorrect navigated array connection geometry poses a high hazard risk in surgical settings. Healthcare providers and patients must stop using the devices immediately.

Alphatec Spine
Due a
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Health & Personal Care
HIGH
FDA DRUG

BioGlo Ophthalmic Strips Recalled Over Sterility Concerns

BioGlo Fluorescein Sodium Ophthalmic Strips are recalled due to sterility issues. The recall affects 184,320 containers distributed nationwide in the USA. Consumers should stop using the product immediately.

Wizcure Pharmaa Private
Lack of
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Health & Personal Care
HIGH
FDA DRUG

Wizcure Pharmaa Recalls Vista Gel Eye Drops Due to Sterility Issues

Wizcure Pharmaa recalled 17,280 cartons of Vista Gel Hypromellose eye drops on December 31, 2025. The recall stems from a lack of assurance of sterility, raising potential health risks for users. Consumers should stop using the product immediately and contact their healthcare provider for guidance.

VISTA HYPROMELLOSE DRY EYE RELIEF
Lack of
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Health & Personal Care
HIGH
FDA DRUG

Wizcure Pharmaa Recalls Fluorescein Sodium Ophthalmic Strips Over Sterility Concerns

Wizcure Pharmaa recalled 10,080 boxes of Fluorescein Sodium Ophthalmic Strips on December 31, 2025, due to sterility issues. The recall affects products packaged in 100-count and 300-count boxes. Consumers should stop using these products immediately and consult healthcare providers for guidance.

C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS
Lack of
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Health & Personal Care
HIGH
FDA DEVICE

Medica Recalls Capillary Tube Kit Over False Potassium Readings

Medica recalled 1,578 units of its Capillary Tubes on December 31, 2025. A systematic positive bias of up to 20% can produce false elevation results in patient potassium levels. Healthcare providers and patients must stop using the device immediately.

Medica
A systematic
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Health & Personal Care
HIGH
FDA DRUG

Wizcure Pharmaa Recalls Eye Drops Due to Sterility Concerns

Wizcure Pharmaa recalled 5,760 cartons of Vista Tears Eye Drops on December 31, 2025. The recall follows a lack of assurance of sterility in the product. Consumers should stop using the drops immediately and contact a healthcare provider for guidance.

Wizcure Pharmaa Private
Lack of
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