1,716 recalls tagged with “cpsc regulated”.
Unichem Pharmaceuticals recalled 230 bottles of Cyclobenzaprine Hydrochloride Tablets on August 27, 2025. The recall stems from a labeling mix-up with Meloxicam tablets, which could lead to serious health risks. Consumers should stop using the product immediately and contact their healthcare provider.
W L Gore & Associates recalled over 52,000 vascular grafts on August 26, 2025, due to reports of delamination. The defect can lead to severe complications such as bleeding or cannulation difficulties. Affected products include multiple model numbers, which were distributed across the United States and internationally.
Abdallah Candies recalled one box of Cream Caramels on August 25, 2025. The product contains undeclared allergens, specifically peanuts and pecans. This poses a serious risk to consumers with nut allergies.
Ultra Violette recalled 49,275 tubes of its Velvet Screen SPF 50 sunscreen on August 22, 2025. Testing revealed SPF levels inconsistent with the label, posing a serious risk. Consumers should stop using the product immediately.
CooperVision recalled 180 units of Sofmed Breathables contact lenses on August 22, 2025. The recall affects one lot manufactured with an invalid sterilization cycle. Patients and healthcare providers must stop using the affected lenses immediately.
CooperVision recalled 90 units of Voyant 1-Day Premium Toric contact lenses on August 22, 2025. The recall affects one lot manufactured with an invalid sterilization cycle. Consumers should stop using the product immediately and follow recall instructions.
GE Medical Systems recalled 29,225 units of the MAC VU360 Acquisition Trunk Cable and Module Holder on August 22, 2025. Users may incorrectly place the Acquisition Module, leading to cable damage and potential overheating. Affected devices were distributed globally, including the U.S. and several other countries.
Abbott Point Of Care recalled 9,067,050 i-STAT CG4+ cartridges on August 21, 2025. The recall stems from a lack of 510(k) premarket clearance reflecting updated sample types and measurement ranges. Healthcare providers must stop using the device immediately and follow recall instructions.
Abbott Point Of Care recalled 547,250 i-STAT EG6+ cartridges on August 21, 2025. The recall stems from a lack of 510(k) premarket clearance for updated sample types and measurement ranges. Healthcare providers and patients must stop using these cartridges immediately.
Folsom Metal Products recalled 3,790 distraction pins on August 21, 2025. The recall affects all lots distributed from August 1, 2020, to July 30, 2025. The labeling lacks a validated shelf life, posing a high hazard risk.
Abbott Point Of Care recalled 8,962,450 i-STAT CG8+ cartridges on August 21, 2025. The recall affects cartridges lacking proper 510(k) premarket clearance for updated sample types. Patients and healthcare providers must stop using these devices immediately.
Folsom Metal Products recalled 2,700 units of distraction pins on August 21, 2025. The recall affects devices with unvalidated shelf life labeling. Patients and healthcare providers must stop using the product immediately.
IBC Technologies recalled CX Combi Boilers on August 21, 2025, due to a burn hazard. The defective models can exceed safe hot water temperatures. Consumers should stop using the affected units immediately.
Bard Peripheral Vascular recalled 1,725 Venclose digiRF Generators on August 21, 2025. The recall stems from software version 3.35 generating false positives for catheter defects. This issue can lead to improper device functionality during clinical use.
Medline Industries recalled 828 units of catheter kits on August 21, 2025, due to potential shape retention issues. The affected products include Model Numbers DYNJ0415366P and DYNJ0415366Q. This recall poses a serious risk to patient safety.
Abiomed recalled 71 Automated Impella Controllers on August 20, 2025. The devices may fail to perform correctly, leading to pump stoppage. Healthcare providers and patients must stop using these devices immediately.
Baxter Healthcare Corporation recalled 13,000 containers of Acetaminophen Injection on August 20, 2025. The recall follows reports of discoloration that may affect product safety. Consumers should stop using the medication immediately and contact their healthcare providers for guidance.
Boston Scientific recalled 10,833 units of its L121 ESSENTIO DR EL Pacemaker on August 20, 2025. The recall addresses a software issue that could prevent the device from operating correctly in certain conditions. Patients and healthcare providers must stop using the device immediately.
Boston Scientific recalled 7,488 ACCOLADE DR EL pacemakers on August 20, 2025. The recall addresses a software issue that may prevent the device from entering Safety Mode. Patients should stop using the device immediately and follow recall instructions.
Boston Scientific recalled 1,380 PROPONENT SR SL pacemakers on August 20, 2025. The recall addresses a software issue that may prevent safety mode activation in ambulatory settings. Healthcare providers and patients must stop using the devices immediately.