1,264 recalls tagged with “fda regulated”.
IKEA is recalling its 365+ VARDEFULL garlic presses after metal fragments can detach and pose a laceration or ingestion hazard. Consumers should stop using the recalled garlic press immediately and return it to any IKEA store for a full refund. If you cannot return to a store, contact IKEA for disposal instructions to receive the refund.
Medline Industries recalled 7,913 reprocessed Inquiry Steerable Diagnostics Catheters due to contamination risks. Some models may contain small residual particulates that can cause severe inflammatory responses or systemic infections. Patients must stop using these devices immediately and contact healthcare providers for further instructions.
Medline recalled 7,913 reprocessed Livewire steerable electrophysiology catheters distributed nationwide in the United States. The devices may contain small residual particulates on patient-contacting surfaces, potentially triggering an inflammatory response or systemic infection. Stop using the device and follow recall instructions from Medline or your healthcare provider.
Medline Industries recalled 7,913 reprocessed Webster CS Catheters for electrophysiology mapping nationwide in the United States. The recall concerns small residual particulates on patient-contacting surfaces that could trigger inflammatory responses or systemic infection. If particulates dislodge and contact circulating blood or the heart, they could cause granulomatous reactions or thrombus, and
Medline Industries recalled 7,913 reprocessed ACUSON AcuNav ultrasound catheters nationwide in the United States. The recall cites residual particulates on patient-contacting surfaces as the hazard. Consumers should stop use and follow manufacturer instructions for recall actions.
Medline Industries, LP is recalling 7,913 reprocessed ViewFlex Xtra ICE Catheters distributed nationwide in the United States. The lots may contain small residual particulates on patient-contacting surfaces. Healthcare providers and patients should stop using the devices immediately and follow recall instructions to obtain replacement or further guidance.
Exela Pharma Sciences recalls 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL, nationwide in the U.S. The recall cites out-of-spec arsenic impurities. Consumers should stop use and contact a healthcare provider. Follow recall notice for guidance and refunds.
S.I.N. Implant System Ltda recalled 4,367 dental implants after reports of potential packaging damage. Improper temperature and storage conditions may compromise product quality and performance. Patients and healthcare providers should stop using these implants immediately and follow the manufacturer's instructions for return.
Ortho-Clinical Diagnostics is recalling 2,320 VITROS LAC Slides nationwide in the United States. The recall affects LAC slides used with VITROS XT 3400 and VITROS XT 7600 analyzers. The issue involves lots coated 0130 and above with Condition Code TH4-63J and can delay lactate tests. Labs should stop using the affected slides and follow manufacturer instructions immediately. Contact Ortho-Clinical
VITROS Chemistry Products LAC Slides recalled after calibration failures on VITROS XT 3400 and VITROS XT 7600 systems. The recall covers catalog 8433880 with 2,908 units distributed nationwide in the US. Manufacturers warn that coating 0130 and above with Condition Code TH4-63J elevates calibration failures, delaying lac test results and potentially impacting patient management. Health providers,病
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 recalled 1,566 bottles of WINN-50 vanazolol dietary supplement sold nationwide. The FDA-listed recall cites degradation of an ingredient and sub-potent Vitamin B12. Consumers should stop using the product and contact the company for refunds or replacements.
Ortoma AB is recalling 261 Inserter Adapters for the Cup Inserter Tool used in hip replacement procedures sold worldwide, including Florida. The defect is weld breakage between the pin and the inserter holder. Surgeons and patients should stop using the devices immediately and follow the manufacturer's recall instructions.
Quallent Pharmaceuticals Health LLC recalls 1,856 bottles of Duloxetine delayed-release capsules due to CGMP deviations and an impurity above FDA interim limits. The recall is active as of August 20, 2025. Patients and providers should stop use and contact Breckenridge Pharmaceutical or a healthcare provider for guidance.
Medline Industries, LP recalled 2,520 Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles sold to U.S. hospitals and healthcare facilities. The lights on the handles may fail to illuminate as intended. Hospitals should stop using the devices immediately and follow recall instructions.
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 recalled 17 ZAP-X Radiosurgery System units worldwide, including US states FL, CO, NJ, NY and several countries. A software defect could cause the collimator to collide with patient shoulders or the patient table during long gantry moves after proximity errors. Clinicians and patients should stop using the device and follow recall instructions from the manufacturer.
Home Health US recalled 4,661 One Step Sterile Lancets for Single Use sold nationwide through Amazon. The recall cites incorrect or missing Unique Device Identifier codes. Consumers should stop using the lancets immediately and follow the recall instructions from Home Health US or their healthcare provider.
Winston Products recalled HydroTech 5/8-inch Expandable Burst-Proof Hoses sold through Home Depot and Walmart. The hoses manufactured on or before August 31, 2024 can burst and create an impact hazard and temporarily impair hearing. Consumers should stop using the hoses immediately and contact Winston Products for a full refund.
Cipla USA Inc. recalls 20,352 packs of Albuterol Sulfate Inhalation Aerosol after failing stability specifications. The defective lots were distributed nationwide in the United States. The issue involves out of specification results in particle size distribution at the 12-month time point. Patients and healthcare providers should stop use and contact Cipla USA for guidance.