These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

3,609 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
Health & Personal Care
HIGH
FDA DEVICE

Agiliti Recalls Adapt Pump Over Microclimate Management Failure

Agiliti Health recalled 4,286 Adapt Pumps on January 21, 2026, after identifying a malfunction. The issue prevents the Microclimate Management function from re-engaging following the Autofirm function. This defect poses a risk to patients relying on the device for safe pressure management.

Agiliti Health - Ellis
Agiliti identified
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Health & Personal Care
HIGH
FDA DEVICE

STAAR Surgical AG EVO+ Visian TICL VTICM5 Recalled for 12.6 mm Length Mismatch (2026)

STAAR Surgical AG recalled 7 EVO+ Visian TICL VTICM5 lenses after finding a labeling error that listed 12.1 mm length but which are 12.6 mm. The mismatch can cause excessive vault and ocular complications. Physicians and patients should stop using the device immediately and follow manufacturer instructions for recall actions.

STAAR Surgical AG
Toric Implantable
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Health & Personal Care
HIGH
FDA DEVICE

Auris Health Recalls Bronchoscopy Device Over Software Issue

Auris Health recalled 173 bronchoscopy devices due to a software malfunction. This issue could lead to improper robotic arm positioning, risking patient safety. The recall affects devices distributed nationwide and in Canada, with the announcement made on January 21, 2026.

Auris Health
Device for
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Health & Personal Care
HIGH
FDA DRUG

Unichem Pharmaceuticals Recalls Doxazosin Tablets Over ID Error

Unichem Pharmaceuticals recalled 60,000 bottles of Doxazosin Tablets on January 21, 2026. The tablets were imprinted with the wrong ID, posing a serious risk to consumers. Healthcare providers and users should stop using the product immediately.

DOXAZOSIN MESYLATE
Tablets/Capsules Imprinted
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Health & Personal Care
HIGH
FDA DEVICE

Stryker Recalls MOLLI 2 Surgical Markers Over Dislodging Risk

Stryker recalled 5,864 units of the MOLLI 2 surgical markers on January 21, 2026. The recall follows concerns that magnetic surgical tools may dislodge markers during procedures. Healthcare providers and patients must stop using these devices immediately.

Stryker
Due to
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Health & Personal Care
HIGH
FDA DRUG

Unichem Pharmaceuticals Recalls Bisoprolol Tablets Over Impurity Risk

Unichem Pharmaceuticals recalled Bisoprolol Fumarate and Hydrochlorothiazide tablets on January 21, 2026. The recall affects tablets that do not meet impurity specifications for N-Nitroso Bisoprolol. Consumers should stop using the product and contact their healthcare provider immediately.

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
cGMP Deviations:
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 Recall 25 Units in 2026

Instrumentation Laboratory is recalling 25 GEM PAK cartridges for the GEM Premier 5000 after complaints of PCSND errors during warm-up. The issues can cause consecutive GEM PAK ejections. The recall affects units distributed worldwide to healthcare facilities. Stop using the affected cartridges and follow manufacturer instructions.

Instrumentation Laboratory
Confirmed customer
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 PAK Recall 2026 for 51 Units

Instrumentation Laboratory recalled 51 GEM Premier 5000 PAK cartridges worldwide after complaints of PCSND errors during warm-up. These errors can cause GEM PAK cartridges to eject. The recall could delay results and affect patient management. Stop using the affected cartridges and follow recall instructions from Instrumentation Laboratory.

Instrumentation Laboratory
Confirmed customer
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 PAK Recall Worldwide in 2026 for PCSND Warm-Up Errors

Instrumentation Laboratory recalled 1,225 GEM Premier 5000 PAK cartridges worldwide on 2026-01-20 after concerns of PCSND errors during warm-up. The errors can trigger GEM PAK cartridge ejection and may require insertion of a new PAK, delaying results. Stop using the device immediately and follow the manufacturer’s recall instructions.

Instrumentation Laboratory
Confirmed customer
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Health & Personal Care
HIGH
FDA DRUG

Acme United MED NAP BZK Antiseptic Towelettes Recalled in 2026 (100-Count)

Acme United Corporation recalled Med Nap BZK Antiseptic Towelettes, 100-count, distributed nationwide. The FDA-listed CGMP deviations raise concerns about manufacturing quality and product safety. Consumers and healthcare providers should stop using the product and follow the recall letter for guidance.

Acme United Corporation
CGMP Deviations
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory Recalls GEM Premier 5000 GEM PAK Cartridges Over PCSND Errors, 1,989 US/3

GEM Premier 5000 recall announced for 1,989 units distributed worldwide, including the US and numerous other countries. The issue involves GEM PAK cartridges experiencing Process Control Solution Not Detected errors during warm-up, causing ejections and potential delays in patient results. Stop using the device and follow manufacturer recall instructions.

Instrumentation Laboratory
Confirmed customer
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory Recalls 7 GEM Premier 5000 Units Over PCSND Errors (2026)

Instrumentation Laboratory recalled seven GEM Premier 5000 units worldwide, including the US. PCSND errors during warm-up may cause GEM PAK cartridges to eject, potentially delaying results. Healthcare providers using these devices should stop using the affected units and contact IL for instructions and a remedy.

Instrumentation Laboratory
Confirmed customer
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 Recall for PCSND Errors in 195 Units (2026)

Instrumentation Laboratory’s GEM Premier 5000 was recalled for 195 units distributed worldwide to hospitals and clinical labs. The recall follows complaints of increased Process Control Solution Not Detected errors during warm-up, which can eject GEM PAK cartridges. Hospitals should stop using the device immediately and contact IL for instructions.

Instrumentation Laboratory
Confirmed customer
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 Recall 1,607 Units Worldwide (2026)

Instrumentation Laboratory recalled 1,607 GEM Premier 5000 units worldwide after complaints of PCSND errors during warm-up that eject GEM PAK cartridges. iQM2 monitors the process and may allow continued use after AutoPAK Validation. Stop using the device and follow IL recall instructions.

Instrumentation Laboratory
Confirmed customer
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