FDA Expands Class I Recall of BMC Luna G3 APAP Devices Over Firmware Defects
The FDA has expanded its most serious recall category for BMC Medical's Luna G3 APAP devices, affecting 20,160 units in the U.S.
The FDA has expanded its most serious recall category for BMC Medical's Luna G3 APAP devices, affecting 20,160 units in the U.S.
The FDA has expanded a recall of Lundberg Family Farms white jasmine rice due to potential contamination with foreign materials.
The recall now includes two lot numbers of Rossdown Meal Starters Black Garlic Chicken Breast Chunks sold at Costco.
The FDA and company environmental sampling found Listeria in the facility; no illnesses have been reported.
The FDA announced an expanded recall of Fi dog supplements due to potential salmonella contamination.
The recall of DELFLEX Dextrose Peritoneal Dialysis Solution has been expanded to include about 156 bags due to potential non-sterility.
The agency announced a recall of deli salads and cream cheese products due to possible Listeria contamination.
Federal regulators say injuries have been reported involving recalled Gizoon six-drawer dressers, which failed stability standards.
FDA adds 3.5 oz bags to the recall of Prospector Popcorn Fudge Brownie Gourmet Popcorn over overstated nutrient declarations.
The FDA has expanded and terminated a Class I recall of Sura Tanmen ramen noodle kits due to undeclared fish in the soup packet.
The recall remains ongoing; consumers who have the product should check the lot codes.
Khong Guan (HQ) recalls 87 cases of frozen dessert dumplings sold in seven states due to undeclared peanuts.
The FDA classified the recall as Class I, its most serious category, citing a reasonable probability of serious harm or death.
FDA classifies recall as Class I, citing jalapenos that may be contaminated with Salmonella.
FDA classifies recall as Class II, saying products may contain glass pieces.
The FDA classified the recall as Class I, the agency's most serious category, due to potential E. coli O145:H28 contamination.
The FDA has closed the recall of Prospector Popcorn Belgian Chocolate Toffee Gourmet Popcorn, originally issued over inaccurate nutrient declarations.
The FDA has closed the recall of Dreyer's Grand Ice Cream's Outshine Grape Fruit Bars, originally initiated over possible glass contamination.
FDA Class II recall of potato sourdough bread sold under three names in Washington state.
The FDA has classified the recall as Class I, indicating a reasonable probability of serious health consequences.
FDA classifies recall as Class II, citing possible glass contamination in frozen fruit bars distributed across multiple states.
FDA classifies recall as Class II; product may contain undeclared wheat, soy, milk, eggs, and coconut.
The FDA has closed the Class II recall of certain levothyroxine sodium tablets due to subpotency, according to an agency enforcement report.
The FDA has closed the Class II recall of certain cyanocobalamin injection vials, confirming the action is complete.
FDA classifies recall of certain 200 mcg levothyroxine sodium tablets as Class II, citing subpotent drug.
FDA classifies the action as Class II, citing CGMP deviations involving tablets with black specks.
FDA Class II recall of certain lots of Levothyroxine Sodium Tablets, 137 mcg, distributed nationwide.
FDA classifies recall of 169,200 vials as Class II due to hair, glass, and paraformaldehyde particles.
The FDA enforcement report dated September 2, 2026, lists a Class II recall of a specific lot of levothyroxine sodium tablets due to subpotency.
American Regent, Inc. recalls 86,100 vials of Papaverine HCl Injection due to particulate matter contamination.
FDA Class II recall of two lots of clobetasol propionate cream 0.05% due to failed content uniformity specifications.
FDA Class II recall of 316,450 vials due to hair, glass, and paraformaldehyde particles.
Shilpa Medicare Limited recalls 18,434 vials of Pemrydi RTU due to reports of green discoloration.
FDA classifies recall of certain 150 mcg levothyroxine sodium tablets as Class II due to subpotency.
FDA Class II recall of 89,775 vials of atropine sulfate injection after contamination with hair, glass, and paraformaldehyde was identified.
The agency considers the recall carried out; affected lots remain identified for anyone still holding the product.
The FDA has closed the Class II recall of certain levothyroxine sodium tablets distributed nationwide.
FDA classifies recall of 98,200 vials as Class II due to hair, glass, and paraformaldehyde particles.
FDA Class II recall of 1,575 airway devices distributed nationwide.
FDA lists action as Class II recall; kits contain a component recalled by the manufacturer.
FDA classifies recall of endoscopic tissue approximation device as Class II due to potential failure to deploy cinch or cut suture.
FDA classifies recall of 21,269 airway devices as Class II due to possible blockage.
The FDA has classified the recall of certain lots of the Emit 2000 Quinidine Assay as Class II, and is urging users to check their inventory against the listed lots and UDI.
The agency has closed the Class II recall of certain heated wire breathing circuits distributed by Medline Industries, LP.
The FDA has announced a Class II recall of certain IMRIS ORT200 operating room tables due to a mechanical failure risk that could cause unintended movement during procedures.
FDA classifies recall of Blanketrol II Model 222S units due to potential overheating and shutdown.
FDA classifies recall of 335 units as Class II due to incorrect labeling on outer shelf boxes.
FDA classifies recall of 1,445 portable renal perfusion systems as Class II due to potential loss of displayed preservation parameters.
The agency has closed the Class II recall of Medline Hudson RCI heated wire breathing circuits, citing completion of the corrective action.
On September 2, 2026, the FDA reported a Class II recall of Merge PACS and Merge OrthoPACS software due to a measurement display issue.