immediate action Recalls

2,679 recalls tagged with “immediate action”.

Health & Personal Care
HIGH
FDA DEVICE

Fisher & Paykel Recall 51,144 Airvo 2 and myAirvo 2 Humidifiers Over Power-Disconnect Audible Alert

Fisher & Paykel Healthcare recalled 51,144 Airvo 2 and myAirvo 2 humidifiers in the United States. The devices may emit an audible alert for less than 120 seconds after power is disconnected. This could delay user awareness to reconnect power and lead to oxygen desaturation. Patients and healthcare providers should stop using the device and await manufacturer instructions.

Fisher & Paykel Healthcare
When unintentionally
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Health & Personal Care
HIGH
FDA DEVICE

GE Medical Systems LOGIQ P9 R4.5 Ultrasound System Recalled for Inaccurate Liver Readings (37 Units)

GE Medical Systems recalled 37 LOGIQ P9 R4.5 ultrasound systems sold nationwide in the United States and globally after regulators flagged UGAP measurements that may misrepresent liver steatosis. The UGAP data may display inaccurate values representing liver steatosis, potentially guiding inappropriate clinical decisions. Clinicians should stop using the affected devices and await recall guidance.

GE Medical Systems
The Ultrasound-Guided
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Health & Personal Care
HIGH
FDA DEVICE

Cardinal Health Salem Sump Stomach Tubes Recalled for ARV Breakage Risk (2025)

Cardinal Health recalled Salem Sump dual-lumen stomach tubes worldwide after ARV breakage complaints. The anti-reflux valve can break when excessive force is used. Healthcare providers and patients should stop using the device and follow recall instructions from the manufacturer.

Cardinal Health
Firm has
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Health & Personal Care
HIGH
FDA DRUG

Glenmark Azelaic Acid Gel Recall Affects 13,824 Tubes Sold Nationwide in 2025

Glenmark Pharmaceuticals Inc. USA recalls 13,824 tubes of azelaic acid gel 15% after CGMP deviations prompted gritty texture complaints. The recall covers nationwide distribution in the United States. Consumers should stop using the product and contact Glenmark for guidance.

Glenmark Pharmaceuticals
CGMP Deviations:
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Food & Beverages
HIGH
FDA FOOD

Haifa Cold Smoked Sea Bass 8 oz Recalled for Listeria Contamination (2025)

Haifa Cold Smoked Sea Bass 8 oz distributed by D & M Smoked Fish is recalled after 348 pieces were found contaminated with Listeria monocytogenes. The recall was issued Sept. 17, 2025, with FDA update on Oct. 22, 2025. Consumers should not eat the product and should contact D & M Smoked Fish for refunds or replacements.

Haifa
Contaminated with
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Health & Personal Care
HIGH
FDA DEVICE

CPM Medical Consultants Recalls 3,317 Fuse ULTRA Foot Plating System IFU Updates (2025)

CPM Medical Consultants recalls 3,317 Fuse ULTRA Foot Plating System Instructions for Use issued nationwide in the United States. The recall addresses sterilization steps that are no longer required in the United States. Healthcare providers should stop using the current IFU and follow CPM’s recall instructions.

CPM Medical Consultants
Instructions for
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Oral Probe Recalled for 5,209 Units Misconfigured as Rectal Probes (2025)

Baxter Healthcare recalled 5,209 oral/axillary probes used with Welch Allyn SureTemp Plus thermometers nationwide in the United States, Canada and Colombia. The probes were inadvertently programmed with the rectal configuration, which can yield a lower temperature reading. Healthcare providers and patients should stop using the affected probes immediately and follow Baxter’s recall instructions.

Baxter Healthcare
Affected oral/axillary
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Health & Personal Care
HIGH
FDA DEVICE

Enterix InSure ONE FIT Recall Affects 201,426 Tests Over False Negatives (2025)

Enterix recalled 201,426 InSure ONE Fecal Immunochemical Test kits after a sensitivity failure linked to Test Card Lot TT241102. The issue may cause false negative results. Healthcare providers and patients should stop using the affected kits and follow the manufacturer’s recall instructions.

Enterix
InSure ONE
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Health & Personal Care
HIGH
FDA DRUG

Park Avenue Compounding Phenylephrine HCI Syringes Recalled Over CGMP Violations

Park Avenue Compounding recalled 858 syringes of Phenylephrine HCI on September 17, 2025, due to CGMP deviations. The recall affects syringes with Lot # 20250813-13D65E and an expiration date of February 9, 2026. Consumers must stop using the product immediately and consult healthcare providers for further guidance.

Park Avenue Compounding
CGMP Deviations
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Food & Beverages
HIGH
FDA FOOD

Lipton Green Tea Citrus Recalled for Undeclared Sugar in 2,854 Cases (2025)

PepsiCo's Lipton Green Tea Citrus RTD bottles, sold at multiple retailers, are recalled after undeclared sugar was found in the finished product. A labeling error shows 25g sugar on the outer case while individual bottle labels show 0g. Consumers should not drink this product and should contact PepsiCo for refunds or replacements.

Lipton
Undeclared sugar
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Health & Personal Care
HIGH
FDA DEVICE

Abiomed Impella Automated Controller Recall Affects 9,177 Units Worldwide (2025)

Abiomed recalled 9,177 distributed Automated Impella Controllers worldwide over purge pressure concerns linked to purge retainer failures. The recall covers multiple product codes, including AIC w/Impella Connect for ECP (1000432) and various packaged controllers. Hospitals and clinicians should stop using the device and follow the manufacturer's recall instructions immediately.

Abiomed
Potential for
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Food & Beverages
HIGH
FDA FOOD

Lawrence Wholesale Shrimp Cocktail Bowls Recalled for Cs-137 Contamination Risk (2025)

Lawrence Wholesale recalled 8,400 cases of Shrimp Cocktail Bowl products sold to Kroger stores in 15 states on Sept. 16, 2025 due to potential Cesium-137 contamination. The recall involves 7oz and 17oz clear plastic bowls with UPCs 011110622952 and 011110624840. Consumers should not consume the product and should contact Lawrence Wholesale LLC for refund or replacement by email.

Lawrence Wholesale
Product manufactured
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Health & Personal Care
HIGH
FDA DRUG

IntegraDose Oxytocin IV Solution Recall 2025 for Subpotent Drug, 853 Bags Nationwide

IntegraDose Compounding Services recalled 853 IV bags of Oxytocin 30 Units/500 mL in 0.9% sodium chloride. The recall is nationwide in the United States. Testing found no oxytocin in the IV bags. Stop using the product and contact IntegraDose or a healthcare provider for guidance.

IntegraDose Compounding Services
Subpotent Drug:
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Food & Beverages
HIGH
FDA FOOD

Lawrence Wholesale Frozen Shrimp Recalled for Cs-137 Contamination (4,871 Cases, 2025)

Lawrence Wholesale recalled 4,871 cases of frozen tail-on shrimp sold through Kroger stores in 16 states. The products were manufactured under insanitary conditions and may be contaminated with Cesium-137. Consumers should not eat these shrimp and should contact Lawrence Wholesale LLC for refunds or replacements.

Lawrence Wholesale
Product manufactured
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Health & Personal Care
HIGH
FDA DRUG

Accord Healthcare Recalls 54,432 Levothyroxine 88 mcg Tablets for Subpotent Potency (2025)

Accord Healthcare recalled 54,432 bottles of Levothyroxine Sodium Tablets, USP, 88 mcg, distributed nationwide in the United States. The recall is due to subpotent assay content observed during long-term stability testing. Patients should stop using the product immediately and contact Accord Healthcare or their healthcare provider for guidance.

Levothyroxine Sodium
Subpotent: During
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