cpsc regulated Recalls

2,056 recalls tagged with “cpsc regulated”.

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 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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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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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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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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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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Health & Personal Care
HIGH
FDA DEVICE

Alcon CONSTELLATION Ultravit 10K & HyperVit 20K Recall for 28,323 Units (2025)

Alcon recalls 28,323 CONSTELLATION Ultravit 10K and CONSTELLATION HyperVit 20K devices used in hospitals worldwide. The recall lists an unspecified hazard. Hospitals should stop using the devices immediately and follow the manufacturer’s instructions. Access the FDA recall notice for details.

Alcon
XXX
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Health & Personal Care
HIGH
FDA DEVICE

FUJIFILM Healthcare CH-200 Recalled for Broken X-ray Tube Shaft in 16 Units

FUJIFILM Healthcare Americas Corp recalled 16 CH-200 X-ray machines in the domestic market. The shaft that mounts the X-ray tube unit on the support may break. Protective parts may fail when the shaft breaks during frontward lifting. Healthcare providers should stop using the device immediately and follow recall instructions.

FUJIFILM Healthcare
It was
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Health & Personal Care
HIGH
FDA DRUG

Graviti Pharmaceuticals Bupropion Hydrochloride XL 300 mg Recall Impacts 46,512 Bottles (2025)

Graviti Pharmaceuticals Private Limited manufactured Bupropion Hydrochloride Extended-Release Tablets XL 300 mg, distributed nationwide by Rising Pharma Holdings, Inc., in 46,512 bottles. The recall cites failed tablet specifications. Stop using the product immediately and contact the manufacturer or your healthcare provider for guidance.

Bupropion Hydrochloride
Failed Tablet/Capsule
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Health & Personal Care
HIGH
FDA DRUG

Skin MD Body Acne Cleanser Recalled for Elevated Benzene Levels (2025)

Skin MD by Dr Monika Kiripolsky recalled its Body Acne Cleanser after detecting elevated benzene levels. The recall covers products associated with Lot # 58170A and Lot # 58172A distributed in CA and GA. Consumers should stop use and seek guidance from a healthcare provider.

Skin MD
Chemical Contamination:
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Health & Personal Care
HIGH
FDA DRUG

Private Label Skin Care Inc. Benzoyl Peroxide 10% Acne Treatment Recalled for Benzene Contamination

A benzoyl peroxide acne treatment sold under mel rx Skin by Private Label Skin Care Inc. is recalled for benzene contamination. The recall covers Lot #58170A and 58172A with expiration date 09/2025 and distribution limited to California and Georgia. Consumers should stop using the product immediately and contact the company for guidance.

Private Label Skin Care
Chemical Contamination:
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Health & Personal Care
HIGH
FDA DEVICE

Diagnostica Stago STA Liatest D-Di Recall 12,740 Units Worldwide in 2025

Diagnostica Stago recalled 12,740 STA Liatest D-Di units distributed worldwide after a potential risk of underestimating D-Dimer levels. The two listed lots may produce falsely low results. Stop using the devices immediately and follow recall instructions from Diagnostica Stago or your healthcare provider.

Diagnostica Stago
A potential
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Health & Personal Care
HIGH
FDA DEVICE

UIH Technologies Recalls 2 uCT ATLAS MD CT X-ray Systems for Mechanical Interference Risk (2025)

UIH Technologies LLC recalled 2 units of the uCT ATLAS MD CT X-ray System sold to U.S. health care providers after reports of potential mechanical interference during table movement. The issue involves third-party outer covers that can become trapped between the patient table and gantry. Hospitals should stop using the devices immediately and follow recall instructions from UIH Technologies LLC.

UIH Technologies
Third-party outer
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Tag Statistics

Total Recalls
2,056

Related Tags

stop use immediatelyreturn for refundfda regulatedimmediate actionadult productgaragenhtsa regulatedreplacement availablechemical hazardpoisoning risklithium batteryinfant product