suffocation risk Recalls

495 recalls tagged with “suffocation risk”.

Health & Personal Care
HIGH
FDA DRUG

Glenmark Carvedilol 25 mg Recall for Nitrosamine Impurity Affects 4,800 Bottles (2025)

Glenmark Pharmaceuticals recalls 4,800 bottles of Carvedilol 25 mg tablets distributed nationwide in the USA. The recall cites CGMP deviations and a nitrosamine impurity exceeding the Acceptable Intake Level. Consumers should stop using the product and contact Glenmark or their healthcare provider for guidance.

Glenmark Pharmaceuticals
CGMP Deviations:
Read more
Health & Personal Care
HIGH
FDA DRUG

Glenmark Carvedilol Tablets Recalled Over Nitrosamine Impurity

Glenmark Pharmaceuticals Inc. recalls 6,432 bottles of Carvedilol Tablets, USP, 12.5 mg, distributed nationwide in the United States. The recall concerns CGMP deviations and the presence of a nitrosamine impurity above the acceptable intake level. Consumers should stop taking the product and contact Glenmark for guidance.

Glenmark Pharmaceuticals Inc.
CGMP Deviations:
Read more
Food & Beverages
HIGH
FDA FOOD

Hi-Tech Pharmaceuticals’ PrimeNutrition PhytoForm Fruits & Greens Recall for Unapproved Drug Claims

Hi-Tech Pharmaceuticals recalled 85,950 units of PrimeNutrition PhytoForm Fruits & Greens Formula after FDA enforcement flagged unapproved drug claims and misbranding. The dietary supplement was distributed to 40+ states before the recall was issued on 2025-08-06 and remains active. Consumers should not consume the product and should seek refund or replacement from Hi-Tech Pharmaceuticals.

Hi-Tech Pharmaceuticals
Unapproved Drug
Read more
Health & Personal Care
HIGH
FDA DEVICE

SeaSpine Orthopedics Recalled 74 Reef TA Inserter Instruments for Reef Interbody System (2025)

SeaSpine Orthopedics recalled 74 Reef TA Inserter instruments used with the Reef Interbody System, distributed worldwide to hospitals and surgical centers. The inserter may cause difficulty disengaging the implant or improper positioning, prolonging surgery and possibly requiring intraoperative revision. Hospitals and surgeons should stop using the device and follow recall instructions from SeaSpn

SeaSpine Orthopedics
Inserter, used
Read more
Health & Personal Care
HIGH
FDA FOOD

Hi-Tech Pharmaceuticals Quercetin Dietary Supplement Recalled for Unapproved Drug Claims and Misbrnd

Hi-Tech Pharmaceuticals recalled 85,950 units of its Quercetin dietary supplement distributed to 40+ states after FDA enforcement found unapproved drug claims and misbranding. The recall, active as of Aug 6, 2025, stems from regulatory concerns rather than a reported health incident. Consumers should stop using the product and contact the company for refunds or replacements.

Hi-Tech Pharmaceuticals
Unapproved Drug
Read more
Health & Personal Care
HIGH
FDA DRUG

Westminster Pharmaceuticals Metoprolol Tartrate 100 mg Recalled for Nitrosamine Above ADI Level (202

Westminster Pharmaceuticals is recalling Metoprolol Tartrate Tablets, 100 mg, 1,000-count bottles distributed nationwide in the United States. The recall concerns CGMP deviations that led to the presence of nitrosamine N-nitroso-metoprolol above the established ADI. Consumers should stop using the product and contact Westminster for guidance.

Metoprolol Tartrate
CGMP Deviations:
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Encore 26 Inflation Device Recalled Over Foreign Particle Contamination

Boston Scientific recalls 39,739 Encore 26 Inflation Devices worldwide after an internal investigation found foreign material particles could migrate from the device into balloon dilation catheters. The high-severity recall affects interventional cardiology and peripheral interventions devices. Stop using immediately and await recall instructions from Boston Scientific or healthcare providers.

Boston Scientific
The Encore
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific NephroMax Kit Recall Covers 458 Units Over Foreign Material Migration Risk

Boston Scientific Corp. recalls 458 NephroMax Kit units using Encore 26 Inflation Devices after an internal review found foreign material particles could migrate from the inflation device into balloon dilatation catheters. The recall affects UPNs M0062101180 and M0062101600 worldwide. Healthcare providers should stop using the device immediately and follow manufacturer recall instructions.

Boston Scientific
The Encore
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific UroMax Ultra Kit MPNs Recalled Over Foreign Material Migration Risk (2025)

Boston Scientific recalled 1,369 Encore 26 Inflation Devices used with balloon dilation catheters after an internal investigation found foreign material particles could migrate into a balloon dilatation catheter. The recall affects 12 UPNs including M0062251200 through M0062251370. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.

Boston Scientific
The Encore
Read more
Health & Personal Care
HIGH
FDA DEVICE

Tandem Diabetes Care Recalls 122,958 t:slim X2 and Tandem Mobi Pumps Over Autobolus Risk (2025)

Tandem Diabetes Care recalled 122,958 insulin pumps nationwide in the United States, including Puerto Rico. A software defect in versions 7.9.0.1 and 7.10.1 for the t:slim X2 and version 7.9.0.1 for the Tandem Mobi paired with a Dexcom G7 sensor can trigger an unexpected automatic insulin correction bolus, raising the risk of hypoglycemia. Users should stop using the affected devices and follow a)

Tandem Diabetes Care
A software
Read more
Food & Beverages
HIGH
FDA FOOD

Hans Kissle Company Recalls 66 Units of Red Bliss Potato Salad for Undeclared Wheat (2025)

Hans Kissle Company recalled 66 units of Red Bliss Potato Salad distributed in MA, RI, CT, NJ and NY. The recall is due to undeclared wheat and a mislabeling that identifies the product as potato salad while the unit contains pasta salad. Consumers should not eat the product and should contact Hans Kissle Company for refund or replacement via email.

Hans Kissle Company
Contains undeclared
Read more
Health & Personal Care
HIGH
FDA DRUG

Hospira Epinephrine Injection Vials Recalled for Lack of Sterility Assurance (2025)

Hospira recalls 49,620 vials of Epinephrine Injection, distributed nationwide in the United States. The recall, active since August 4, 2025, targets vials with NDC 0409-4933-05 and case NDC 0409-4933-10. The hazard is lack of assurance of sterility. Health professionals should stop using the product and contact Pfizer or a healthcare provider for guidance.

Epinephrine
Lack of
Read more
Health & Personal Care
HIGH
FDA DEVICE

AVID Medical JACK421-04 ENT PACK Recalled for Sterility Risk (2025)

AVID Medical recalled 57 JACK421-04 ENT PACK convenience kits nationwide in Florida. The open header bag seals could compromise sterility. Consumers should stop using the device and follow manufacturer instructions for recall resolution.

AVID Medical
Potential for
Read more
Health & Personal Care
HIGH
FDA DEVICE

AVID Medical CPT BASIC IR PACK 1646381 Recall for Sterility Risk (2025)

AVID Medical recalls 228 CPT BASIC IR PACKs sold nationwide, including Florida, due to open header bag seals that may compromise sterility. The recall is active as of September 17, 2025. Consumers should stop use and follow manufacturer instructions.

AVID Medical
Potential for
Read more