LeMaitre Vascular recalled 10 Artegraft Collagen Vascular Grafts on August 25, 2025, due to incorrect labeling. The devices lack CE and UKCA marks and are missing essential patient information. No distribution occurred within the U.S., but the affected products were sent to Great Britain and Switzerland.
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact LeMaitre Vascular, Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The recalled models are AG630M, AG636M, AG730M, AG740M, and AG845M. These devices were distributed internationally, with no sales in the U.S. The expiration date for the grafts is July 28, 2027.
The Artegraft devices were labeled incorrectly, lacking the required CE and UKCA marks. Missing patient leaflets and implant cards can lead to improper use and potentially serious health risks.
There are no reported incidents or injuries associated with the recalled grafts. The recall is a proactive measure to ensure patient safety.
Patients and healthcare providers should cease use of the recalled grafts immediately. Contact LeMaitre Vascular, Inc. or your healthcare provider for further instructions.
For more information, contact LeMaitre Vascular at the telephone number provided in the recall notification. Additional details can be found at the FDA recall website.
Get instant alerts for recalls that affect you. Free forever.
Glenmark Pharmaceuticals recalled nearly 97,000 packs of Ondansetron Orally Disintegrating Tablets on December 30, 2025. Defective blister packs may not fully seal, leading to tablets falling out. Consumers should stop using the product immediately and contact healthcare providers.
Novo Nordisk recalled Wegovy (semaglutide) injections on December 19, 2025, after discovering hair in prefilled syringes. The contamination poses a serious hazard to consumers. The recall affects all units distributed nationwide.
Novo Nordisk recalled Wegovy (semaglutide) Injection on December 19, 2025, due to hair found in a prefilled syringe. The recall affects products distributed nationwide in the United States. Consumers should stop using the product immediately and contact their healthcare provider.
Zydus Pharmaceuticals recalled over 2,100 bottles of TraZODONE Hydrochloride Tablets on December 19, 2025. Some tablets have surface dents that may affect medication integrity. Consumers should stop using the product immediately and seek guidance from healthcare providers.
CareFusion 213, LLC recalled 106,400 units of ChloraPrep Triple Swabsticks on December 17, 2025. The recall occurred due to a lack of assurance of sterility. Consumers must stop using the product immediately and contact CareFusion for guidance.
Merck Sharp & Dohme LLC recalled 845 kits of Noxafil Powdermix on December 12, 2025. The recall follows the discovery of potential metal particulates in the product. Consumers should stop using the medication immediately and contact their healthcare provider for further guidance.
Merck Sharp & Dohme LLC recalled 3 single-dose kits of Emend (aprepitant) on December 12, 2025. The recall stems from the potential presence of metal particulates in the medication. Consumers should immediately stop using the product and contact their healthcare provider for guidance.
Beaver-Visitec International recalled five units of the OME6000U Laser and Endoscopy System on December 5, 2025. The recall stems from a manufacturing deviation where ferrites required for the USB cable were not installed. This omission poses a high electrical hazard risk to patients and healthcare providers.