fda regulated Recalls

Medline Reprocesses 7,913 Electrophysiology Catheters for Safety Risks

Medline Recalled 7,913 Reprocessed ACUSON AcuNav Ultrasound Catheters for Intracardiac Imaging

Exela Pharma Sciences 4.2% Sodium Bicarbonate Injection Recalled Over Arsenic Impurity Out-Of-Spec

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.

Over 4,300 S.I.N. Implant EPIKUT Dental Implants Recalled Due to Quality Concerns

Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be packaging damage, which could compromise product quality and performance.

Ortho-Clinical Diagnostics Recalls 2,320 VITROS LAC Slides for Calibration Failures on XT Systems (W

Ortho-Clinical Diagnostics LAC Slides Recalled Over Calibration Failures on VITROS Systems

Pfizer Levoxyl Recall: Subpotent Levoxyl 50 mcg Tablets, 29,004 Bottles in U.S. Market (2025)

Pfizer's Levoxyl 50 mcg levothyroxine tablets are recalled due to subpotency. About 29,004 bottles distributed in the U.S. since distribution. Consumers should stop use and contact their healthcare provider for guidance.

Dynamic Sports Nutrition Recall: WINN-50 Vanazolol Dietary Supplement Sub-Potent for Vitamin B12 (H-

Dietary supplement involved degradation of an ingredient. Product is sub-potent for Vitamin B12 not meeting label claims.

Ortoma AB Recalls 261 Inserter Adapters for Hip Cup Tools (2025)

Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.

Medline Recalls 2,520 Kits With Flexicare Laryngoscope Handles Over Lighting Failure (2025)

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.

Quallent Duloxetine Delayed-Release Capsules 60 mg Recall Expanded for Impurity Above FDA Interim Lm

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Medline Recalls 596 Flexicare BritePro Solo Fiber Optic Laryngoscope Handles in 2025

Medline Industries, LP recalled 596 Medline kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles. The light may fail to illuminate as designed. Healthcare providers should stop using the devices immediately and follow recall instructions.

Zap Surgical Systems ZAP-X Radiosurgery System Recalled for 17 Units Worldwide in 2025

Home Health US Recalled 4,661 One Step Sterile Lancets for Single Use (2025)

Due to incorrect/lack of Unique Device Identifier (UDI) codes.

Cipla USA Albuterol Sulfate Inhalation Aerosol Recall Expanded for Stability Variance (2025)

Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.

Minongad LED Gloves ST01 Recalled for Battery Ingestion Hazard Sold on Amazon (2025)

Winston Products HydroTech 5/8-Inch Expandable Burst-Proof Hose Recall 2025

Beckman Coulter MicroScan Neg MIC 56 Panels Recalled for Contamination Risk (2026)

Due to the likely presence of contamination in well(s).

AUM Pharmaceuticals Isopropyl Alcohol Prep Pads Recall: 500 Cases Active, High Hazard

Middlefield Original Cheese Cooperative Pepper Jack Cheese Recalled for Listeria Contamination (2025

Potential contamination with Listeria monocytogenes