immediate action Recalls

2,756 recalls tagged with “immediate action”.

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
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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 Recalling 10 GEM Premier 5000 PAK Cartridges for PCSND Error During Warm‑

Instrumentation Laboratory recalled 10 GEM Premier 5000 PAK cartridges sold worldwide after reports of increased PCSND errors during warm‑up. The issue can cause GEM PAK ejections and delays in results. Clinicians and labs should follow the manufacturer’s recall instructions and seek guidance from their healthcare provider.

Instrumentation Laboratory
Confirmed customer
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory Recalling 1,126 GEM PAK Cartridges for GEM Premier 5000 Over PCSND Errors

Instrumentation Laboratory issued a high-severity recall for 1,126 GEM PAK cartridges used with the GEM Premier 5000. The recall cites increased PCSND errors during warm-up that can cause consecutive GEM PAK ejections. The issue may delay patient results. Hospitals should halt use and follow manufacturer instructions immediately.

Instrumentation Laboratory
Confirmed customer
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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
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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 DRUG

Medi-First Antiseptic Wipes Recalled for CGMP Deviations in 2026, 100 Wipes per Box

ACME United Corporation recalled Medi-First Antiseptic Wipes sold nationwide in the United States. The recall cites CGMP deviations that could affect product quality. Consumers and healthcare providers should stop using the wipes immediately and contact ACME United Corporation or a healthcare provider for guidance.

Medi-First Antiseptic Wipes
CGMP Deviations
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Health & Personal Care
HIGH
FDA DRUG

ACME UNITED Recalls Max Packaging Antibacterial Towelette for CGMP Deviations (2026)

ACME UNITED recalled Max Packaging Antibacterial Towelette nationwide in the United States after CGMP deviations were identified. Manufacturing quality deviations prompted the recall, classified as Class II and labeled as high hazard. Stop using the product immediately and contact ACME UNITED CORPORATION or your healthcare provider for guidance.

ACME UNITED
CGMP Deviations
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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
HIGH
FDA DRUG

Dynarex Obstetrical Towelettes Cleanser Recall 2026 for CGMP Deviations

Dynarex Obstetrical Towelettes Cleanser is under an active FDA recall as of Jan. 20, 2026. The recall cites CGMP Deviations that could affect product quality. Consumers and healthcare providers should stop using the product immediately and contact ACME United Corporation or a healthcare provider for guidance.

BZK PADS
CGMP Deviations
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Health & Personal Care
HIGH
FDA DRUG

ACME United's First Aid Only BZK Towelettes Recall 2026: CGMP Deviations Prompt Nationwide Action

ACME United Corporation recalled First Aid Only BZK Antiseptic Towelettes nationwide after CGMP deviations were identified in manufacturing. The products carry NDC 0924-7116-03 and come in 50-wipe packages. Consumers should stop using the product and contact the company for guidance. A recall notice will be mailed to affected customers.

First Aid Only
CGMP Deviations
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Health & Personal Care
HIGH
FDA DRUG

First Aid Only BZK Antiseptic Towelettes Recall for CGMP Deviations (2026)

First Aid Only BZK Antiseptic Towelettes are recalled nationwide in 2026 after CGMP Deviations were identified at the Acme United Corporation facility. The recall cites CGMP Deviations that could affect product quality. Consumers should stop using the product and contact Acme United Corporation for guidance.

First Aid Only BZK Antiseptic
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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Health & Personal Care
HIGH
FDA DRUG

ACME United Recalls Wipes Plus Hand Sanitizing Alcohol Free BZK Wipes (2026)

ACME United recalled Wipes Plus Hand Sanitizing Alcohol Free BZK Wipes sold nationwide on Jan. 20, 2026. The recall cites CGMP deviations in manufacturing. Consumers and healthcare providers should stop using the product immediately and contact ACME United or their healthcare provider for guidance.

ACME United
CGMP Deviations
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Health & Personal Care
HIGH
FDA DRUG

ACME UNITED Antimicrobial Hand Wipes Recall 2026 for CGMP Deviations

ACME UNITED recalled antimicrobial hand wipes manufactured for Custom Packaging Co., Inc. and distributed nationwide in the United States. The recall cites CGMP deviations in manufacturing. Consumers and healthcare providers should stop using this product immediately and contact ACME UNITED for guidance.

ACME UNITED
CGMP Deviations
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Health & Personal Care
HIGH
FDA DRUG

Dynarex BZK Antiseptic Towelettes 100-Count Recalled for CGMP Deviations (2026)

Dynarex recalled 100-pack BZK Antiseptic Towelettes sold nationwide after FDA enforcement cited CGMP deviations. The recall covers multiple lots, including Lot 52347-R, 52348-R, 52349-R, 52350, 52351-R, 52352, Exp. Date Mar 2027 and Exp. Date Jun 2027. Consumers should stop using the product immediately and contact ACME UNITED CORPORATION or their healthcare provider for guidance.

Dynarex
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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Tag Statistics

Total Recalls
2,756

Related Tags

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