370 recalls tagged with “nhtsa regulated”.
Abbott Point Of Care recalled 547,250 i-STAT CG8+, EG7+, and EG6+ cartridges distributed nationwide in the United States. The recall concerns lack of 510(k) premarket clearance for updated sample types and measurement ranges. Hospitals and clinicians should stop using these cartridges immediately and follow Abbott’s recall instructions.
Abbott Point Of Care recalled 6,115,950 i-STAT EG7+ cartridges distributed nationwide in the United States. The recall centers on lack of 510(k) clearance for updated sample types and measurement ranges. Healthcare providers and patients should stop using the cartridges immediately and follow Abbott’s recall instructions for next steps.
Chevrolet Corvette owners are being notified by General Motors dealers to fix a fuel-spill risk in 2023–2026 Corvette models. During refueling, excess fuel may spill into the vehicle fuel-filler pocket and reach an ignition source, increasing fire risk. Dealers will install a shield at no charge. Letters were mailed Sept. 10, 2025. Owners should contact Chevrolet customer service at 1-800-222-1020
Bard Peripheral Vascular recalled 1,725 Venclose digiRF Generators with software version 3.35. The recall centers on a catheter verification feature that can produce false positives and disable compatible EVSRF catheters. The worldwide distribution includes the United States. Patients and healthcare providers should stop using the device and await further instructions from the manufacturer.
Baxter Healthcare’s Acetaminophen Injection 1000 mg/100 mL is recalled. The nationwide recall covers 13,000 containers with lot 24A27G66 and expiring 12/31/2025. The FDA lists discoloration as the hazard. Stop using and contact Baxter or a healthcare provider.
Mercedes-Benz USA recalls 2025 GLC 350E 4MATIC and related EQE/GLC models due to a loose steering coupling bolt. The defect may loosen the steering rack, risking loss of control. Dealers will tighten bolts at no charge. MBUSA notified owners on Oct 6, 2025.
The FDA recalls 26,628 cartons of Carvedilol Tablets USP 12.5 mg distributed nationwide. The product fails CGMP standards due to NNCI impurity exceeding FDA limits. Stop using and contact The Harvard Drug Group LLC and Rugby Laboratories for guidance.
Boston Scientific recalled 41,009 pacemakers worldwide after a software flaw could prevent Safety Mode activation. The defect affects devices in the ACCOLADE family and several related models. Patients and healthcare providers should stop using the device immediately and follow recall instructions from the manufacturer.
Boston Scientific recalled 63,851 L231 pacemakers worldwide on August 20, 2025. The recall covers the ACCOLADE family and related devices, including PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL, and VISIONIST and VALITUDE CRT-Ps. The software flaw could prevent Safety Mode from initiating when needed. Stop using the device and contact your healthcare provider for instructions immediately.
Boston Scientific recalled 4,841 pacemakers worldwide on 2025-08-20 after a software issue could prevent Safety Mode activation in ambulatory settings. The affected devices include ACCOLADE family pacemakers and VISIONIST and VALITUDE CRT-Ps. Patients and healthcare providers should stop using the device immediately and follow the recall instructions in the notification letter.
FDA recalls READYPREP PVP, povodone-iodine 10% topical antiseptic. Medline Industries issued the nationwide recall. Subpotent drug is the reason. Consumers should stop using the product immediately.
Lannett Company Inc. recalls 4,848 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets. A bottle labeled 10 mg 100-count contained a 5 mg tablet. Two bottles were affected. Consumers and healthcare providers should stop using this product immediately. Contact Lannett or a healthcare provider for guidance.
Amneal Pharmaceuticals LLC is recalling 7,228 bottles of CHLORPROMAZINE HYDROCHLORIDE tablets sold nationwide in the United States. Packaging coils used in the bottles tested positive for a microorganism, though no tablets were contaminated. Stop using this product immediately and contact Amneal or your healthcare provider for guidance.
Amneal Pharmaceuticals products containing chlorpromazine hydrochloride are recalled nationwide after the FDA-linked notice identifies a foreign substance in packaging material. No tablets were contaminated. The recall was issued August 18, 2025 and updated September 10, 2025. Consumers and healthcare providers should stop using the affected lots immediately and contact Amneal for guidance.
Aesculap AG recalls the ELAN 4 Fixed Duraguard Long device, Model GB943R, after mislabeling errors were discovered. The U.S. distribution reached Missouri with international distribution to multiple countries. Healthcare providers should stop using the device immediately per manufacturer instructions.
Maquet Cardiovascular recalls the Heartstring III Proximal Seal System, a 3.8 mm intravascular anastomosis occluder used by hospitals worldwide. Three failure modes have been identified: loading failure, deployment failure, and failure to provide adequate hemostasis. Healthcare facilities should stop using the device immediately and follow manufacturer recall instructions.
Viewrail recalls the electronic LED module E2-WR used with floating stairs and rails after a fire hazard was identified. The recall covers modules located inside the metal stringer tube at the back of the stairs. The recall was announced by the CPSC on 2025-08-14. Consumers should stop using the module and contact Viewrail for a replacement or refund.
Philips North America has issued a recall for 81 IQon Spectral CT systems, Model 728332, sold worldwide. The patient support table may descend unexpectedly to the lowest position due to ball screw misalignment after a replacement. Stop using the device immediately and follow manufacturer recall instructions.
Beckman Coulter recalled the UniCel DxH 800 COULTER Cellular Analysis System configured with the Led HGB photometer. The recall affects models B24802, 629029, and B63322 and related configurations. A design-linked issue can yield erroneously high hemoglobin results when samples have elevated white blood cell counts. Stop using the device and follow the manufacturer’s recall instructions. Contact a
Penner Patient Care recalled 45 Penner Pacific Bathing Spa units distributed nationwide in the United States. The devices do not bear a unique device identifier. Patients and healthcare providers should stop using this device immediately and follow the recall instructions provided by the manufacturer.