LeMaitre Vascular Artegraft 10-Unit Recall 2025 for Labeling Errors
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
2,756 recalls tagged with “immediate action”.
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
One lot manufactured with an invalid sterilization cycle.
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
One lot manufactured with an invalid sterilization cycle.
Ultra Violette Mini Mates SPF 50 kit sold nationwide in the U.S. is recalled. Testing showed SPF results ranging from 4 to 64. The recall is issued by Grace & Fire USA Inc. The public was notified by letter.
Labeling includes shelf life that has not been validated.
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Labeling includes shelf life that has not been validated.
Labeling includes shelf life that has not been validated.
Undeclared allergens (sesame and soy).
Labeling includes shelf life that has not been validated.
Labeling includes shelf life that has not been validated.
Product contains undeclared Soy and Sesame
Labeling includes shelf life that has not been validated.
General Motors, LLC (GM) is recalling certain 2023–2026 Chevrolet Corvette vehicles equipped with a left-side radiator/fan combination. Excess fuel may spill into the vehicle fuel-filler pocket during refueling and leak onto an ignition source.
