infant product Recalls

794 recalls tagged with “infant product”.

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 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
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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
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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Health & Personal Care
HIGH
FDA DRUG

Med Nap Cleansing Towelettes Recall Expanded Over CGMP Deviations (2026)

ACME United Corporation recalls Med Nap Cleansing Towelettes, 5"x7" Benzalkonium Chloride 0.13%, distributed nationwide. CGMP Deviations prompted the recall. Stop using the product now and contact ACME United or a healthcare provider for guidance.

MED NAP CLEANSING TOWELETTE
CGMP Deviations
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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 489 GEM Premier 5000 PAK Cartridges Over PCSND Errors in Warm-Up

Instrumentation Laboratory recalls 489 GEM Premier 5000 PAK cartridges worldwide after reports of Process Control Solution Not Detected errors during warm-up. iQM2 monitors the testing process and may allow continued use after AutoPAK Validation. The recall highlights potential operational disruptions in patient management.

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

Siemens Healthcare Diagnostics Recalls 4,885 Atellica CH Urine Albumin Tests for False Low Results (

Siemens Healthcare Diagnostics recalled 4,885 Atellica CH Urine Albumin tests in 2026 after detecting falsely depressed results. The manufacturer notes that any urine albumin concentration above 40.0 mg/dL may report values from 6.2 to 40.0 mg/dL. Stop using the device immediately and follow the recall instructions.

Siemens Healthcare Diagnostics
Falsely depressed
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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

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

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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Food & Beverages
HIGH
FDA FOOD

Frederik's by Meijer Focaccia Bread Recalled for Metal Fragments (2026)

Frederik's by Meijer Slow-Roasted Tomato & Parmesan Focaccia Bread recalled after metal fragments were found in 23,459 cases. The recalls spans Frederik's by Meijer, Fresh & Simple, HT Traders and Trader Joe's focaccia products. The metal fragments were traced to roasted tomatoes from an ingredient supplier. Stop using the product and contact the supplier for refunds or replacements.

Bakkavor
Metal fragments
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Food & Beverages
HIGH
FDA FOOD

Bader Enterprises Recalls Premium Food Jordan Almonds in 2.0 oz & 3.5 oz Packaging (2026 Recall)

Bader Enterprises recalls 60 pounds of Premium Food Jordan Almonds sold in New Jersey and New York. The product contains undeclared wheat and blue color additives. Consumers who purchased the product should not consume it. Contact Bader Enterprises for refund or replacement information via two or more notification methods.

Bader Enterprises
Contains undeclared
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Recalled Greatale Self-Feeding Pillow
HIGH
CPSC

Greatale Recalls Self-Feeding Pillows Due to Suffocation Risk

Greatale recalled self-feeding pillows on January 15, 2026, due to a serious risk of aspiration and suffocation in infants. The pillows can hold a bottle at an unsafe angle, preventing infants from pulling away. Consumers must stop using the pillows immediately and return them for a full refund.

Greatale
The recalled
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Tag Statistics

Total Recalls
794

Related Tags

electrical hazardchemical hazardtoddler productadult productimmediate actionreturn for refundreplacement availablefda regulatednhtsa regulatedstop use immediatelybattery poweredlithium battery
    infant product Recalls | RecallRadar