replacement available Recalls

1,215 recalls tagged with “replacement available”.

Health & Personal Care
HIGH
FDA DEVICE

Roche Cobas Pro 1,261-Unit Recall Over Spline-Calibration Error (2026)

Roche Diagnostics issued a nationwide recall of 1,261 Cobas Pro systems with cobas c 503 units in the United States. A software defect can cause erroneous, non-monotonic calibrations for spline-type assays. Labs should stop using the devices immediately and follow the manufacturer's recall instructions.

Roche Diagnostics Operations
Software defect,
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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 DRUG

ACME UNITED Instant Hand Sanitizing Wipes Recalled for CGMP Deviations (2026)

ACME UNITED recalled instant hand sanitizing wipes nationwide after FDA flagged CGMP deviations. The product, labeled for Children’s Healthcare of Atlanta and manufactured in the USA, contains benzalkonium chloride 0.13% and is sold 1,000 wipes per case under NDC 0924-7130-00. Consumers and healthcare providers should stop using this product immediately and contact ACME UNITED CORPORATION for next

ACME UNITED
CGMP Deviations
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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 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 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 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 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 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 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 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

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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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

Palmetto Gourmet Foods Vegetarian Chicken Flavor Ramen Recalled for Yellow #5 (5,664,960 Units, 2026

Palmetto Gourmet Foods recalled 5,664,960 three-ounce packages of Vegetarian Chicken Flavor Ramen sold at multiple retailers nationwide after undeclared Yellow #5 was detected. The recall covers products with a Best By Date before 01/15/2027. Consumers should not eat this product and should contact Palmetto Gourmet Foods for refund or replacement information by mail.

Palmetto Gourmet Foods
Product contains
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Health & Personal Care
HIGH
FDA DEVICE

GE Healthcare Centricity Universal Viewer ZFP Recall 250 Units Worldwide in 2026

GE Healthcare recalled 250 Centricity Universal Viewer Zero Footprint Client units distributed worldwide after finding a risk that patient information may not match displayed images in certain workflows. The issue affects ZFP v6.0 SP11.6, SP11.6.0.1 and SP11.6.1 when Patient Timeline is installed. Hospitals should stop using affected units and await instructions from GE Healthcare.

GE Healthcare
Under certain
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