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

3,615 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

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
Read more
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
Read more
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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Health & Personal Care
HIGH
FDA DRUG

Dukal BZK Antiseptic Towelettes Recalled for CGMP Deviations (2026)

Nationwide recall of Dukal BZK Antiseptic Towelettes due to CGMP deviations. The products are manufactured for Dukal, LLC in Ronkonkoma, NY and distributed across the United States. Stop using immediately and contact ACME United Corporation for guidance.

Dukal
CGMP Deviations
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory Recalled 180 GEM Premier 5000 PAK Cartridges for PCSND Errors (2026)

Instrumentation Laboratory recalls 180 GEM Premier 5000 PAK cartridges distributed worldwide after reports of PCSND errors during warm-up. During warm-up, GEM PAKs may eject and require insertion of a new GEM PAK. Hospitals should stop using the affected cartridges and follow the manufacturer's recall instructions.

Instrumentation Laboratory
Confirmed customer
Read more
Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 Recall of 130 GEM PAK Cartridges for PCSND Errors (2026)

Instrumentation Laboratory recalled 130 GEM PAK cartridges for the GEM Premier 5000 after confirmed complaints of Process Control Solution Not Detected errors during warm-up. The issue can cause GEM PAKs to eject and delay test turnaround. Healthcare facilities should stop using the affected cartridges and follow manufacturer instructions for recall guidance.

Instrumentation Laboratory
Confirmed customer
Read more
Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 GEM PAK Recall Affects 74 Units Worldwide

A worldwide distribution recall covers 74 GEM PAK cartridges for the GEM Premier 5000. The issue involves PCSND errors during warm-up that can trigger ejection of GEM PAKs and may delay results. Institutions should follow recall instructions from Instrumentation Laboratory and notify healthcare teams immediately.

Instrumentation Laboratory
Confirmed customer
Read more
Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 PAK Recalled for PCSND Warm-Up Errors (30 Units, 2026)

Instrumentation Laboratory is recalling 30 GEM Premier 5000 PAK cartridges distributed worldwide, including the United States. The affected cartridges may experience PCSND errors during warm-up, causing GEM PAKs to eject. Stop using the product and follow recall instructions from the manufacturer for refunds or replacements.

Instrumentation Laboratory
Confirmed customer
Read more
Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 GEM PAK Recalled for 1,629 Units Worldwide (2026)

Instrumentation Laboratory recalled 1,629 GEM Premier 5000 cartridges worldwide on Jan. 20, 2026 after customers reported increased PCSND errors during warm-up. Consecutive ejections may prolong turnaround times and delay results. Stop using affected GEM PAKs and follow recall instructions from the manufacturer.

Instrumentation Laboratory
Confirmed customer
Read more
Health & Personal Care
HIGH
FDA DRUG

ACME United BZK Antiseptic Towelettes Recall for CGMP Deviations (2026)

ACME United Corporation recalled BZK Antiseptic Towelettes sold for Food Service Resources nationwide after CGMP deviations were found. The recall is Class II and high risk. Consumers and healthcare providers should stop using this product immediately and follow recall guidance.

ACME United
CGMP Deviations
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory Recalls 352 GEM PAK Cartridges for GEM Premier 5000 Over PCSND Errors

Instrumentation Laboratory recalls 352 GEM PAK cartridges for the GEM Premier 5000 worldwide due to increased PCSND errors during warm-up, risking delayed results. Medical facilities should stop using affected GEM PAKs and follow recall instructions. Manufacturers will provide further guidance to healthcare providers and patients.

Instrumentation Laboratory
Confirmed customer
Read more
Health & Personal Care
HIGH
FDA DRUG

Med-Nap Cleansing Towelettes Recall 2026 for CGMP Deviations

Med-Nap Cleansing Towelettes, manufactured by Acme United Corporation, were recalled nationwide on January 20, 2026. The recall cites CGMP deviations in manufacturing for benzalkonium chloride 0.13% towelettes. Consumers and healthcare providers should stop using the product immediately and contact Acme United for guidance.

Med-Nap Cleansing Towelettes
CGMP Deviations
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Health & Personal Care
MEDIUM
FDA DRUG

Green Guard Antiseptic Wipes Recall 2026 Over CGMP Deviations

Green Guard Antiseptic Wipes, distributed nationwide by ACME United Corporation, are being recalled as of January 20, 2026. FDA enforcement cites CGMP deviations in manufacturing for the benzalkonium chloride wipes, NDC 47682-056-73. Consumers and healthcare providers should stop using the product immediately and contact ACME United for guidance on refunds or replacements.

Green Guard Antiseptic Wipes
CGMP Deviations
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Food & Beverages
HIGH
FDA FOOD

Cacao Art Recalls Dark Chocolate Over Undeclared Milk Allergen

Cacao Art recalled 128 bars of Crunchy Caramel artisan dark chocolate on January 20, 2026. The product contains an undeclared allergen, milk, which poses a risk to consumers with dairy allergies. The chocolate was distributed only in Florida.

Cacao Art
Undeclared allergen
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