fda regulated Recalls

1,264 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DEVICE

B Braun Medical PERIFIX FX Epidural Tray Recalled for Lid-Position Issue (21,270 Units)

B Braun Medical recalled 21,270 PERIFIX FX Continuous Epidural Anesthesia Tray units distributed nationwide to hospitals and surgical centers after a lid-position defect was identified in the catheter connector. The defect allows the catheter connector lid to be in the incorrect position. Healthcare facilities and clinicians should stop using the device immediately and follow the manufacturer’s or

B Braun Medical
Potential for
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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 200 Recalls Salem Sump Dual-Lumen Stomach Tubes Over ARV Breakage (2025)

Cardinal Health 200 LLC expanded a worldwide recall of Salem Sump silicone dual-lumen stomach tubes after complaints of anti-reflux valve breakage. The valve can fracture under normal use, potentially compromising tube function. Healthcare providers and patients must stop using the device immediately and follow the manufacturer’s recall instructions.

Cardinal Health 200
Firm has
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Health & Personal Care
HIGH
FDA DEVICE

GE Medical Systems LOGIQ P10 Ultrasound System Recalled for UGAP Data Inaccuracy (31 Units, 2025)

GE Medical Systems recalled 31 LOGIQ P10 R4.5 HD ultrasound systems sold nationwide in the United States and globally after discovering UGAP measurements may misstate liver steatosis. The UGAP data may display inaccurate values representing liver steatosis. Healthcare providers and patients should stop using the device immediately and follow the manufacturer’s recall instructions.

GE Medical Systems
The Ultrasound-Guided
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Food & Beverages
HIGH
FDA FOOD

Taproom Gourmet 15lb Bulk Madison Mix Recalled Over Undeclared Allergens

Taproom Gourmet recalled 3,547 cases of 15lb bulk Madison Mix after undeclared allergens were found. The recall cites no ingredient label as the defect. Consumers should not consume the product and should seek refund or replacement from Egress Capital Partners Inc.

Taproom Gourmet
No ingredient
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Health & Personal Care
HIGH
FDA DEVICE

Cardinal Health 200 Salem Sump Anti-Reflux Valve Recalled for Breakage Risk (2025)

Cardinal Health 200, LLC recalls all lots of the Salem Sump Anti-Reflux Valve worldwide after complaints of valve breakage. The recall covers CE-marked valves with multiple identifiers. Hospitals and clinicians should stop using the device immediately and follow manufacturer instructions. This notice alerts providers to check for the affected code and act now.

Cardinal Health
Firm has
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Food & Beverages
HIGH
FDA FOOD

Taproom Gourmet Bulk Fifth Avenue Mix Recalled for No Ingredient Label and Allergens

Taproom Gourmet recalled 3,547 cases of 18lb and 20lb bulk Fifth Avenue Mix sold in six states after undeclared peanuts, almonds, cashew, and soy were found. The recall classifies the hazard as HIGH. Consumers should discard the product or return for refund or replacement via Egress Capital Partners Inc.

Taproom Gourmet
No ingredient
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Health & Personal Care
HIGH
FDA DEVICE

B Braun Medical PERIFIX FX Epidural Tray Recalled for Lid Misalignment in 48,110 Units (2025)

B Braun Medical Inc. recalled 48,110 units of the PERIFIX FX Continuous Epidural Anesthesia Tray nationwide to hospitals and surgical centers. The recall cites a potential for the lid of the catheter connector to be in the incorrect position. Hospitals and clinics should stop using the device and contact B Braun Medical for instructions.

B Braun Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Cook Medical Zenith Alpha 2 Thoracic Graft Recall Affects 695 Devices in 2025

Cook Medical recalled 695 Zenith Alpha 2 Thoracic Endovascular Grafts distributed to hospitals domestically and internationally. A defect could cause PTFE coating scrapings to be released during deployment, risking intravascular embolization. Healthcare providers and patients should stop using the device and follow the manufacturer’s recall instructions.

Cook Medical
Affected devices
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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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Tag Statistics

Total Recalls
1,264

Related Tags

cpsc regulatedimmediate actionstop use immediatelyreturn for refundreplacement availableelectrical hazardpoisoning riskkitchenfederal law violationholiday productnhtsa regulatedelectronic