Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
Intuitive Surgical is recalling Intuitive 8 mm SureForm 30 Gray Reloads (Reference Numbers 48230M-05 and 48230M-06) because they may produce an incomplete staple line during curved-tipped stapler operations.
AVID Medical recalls Halyard Cardiac Cath Pack kits (Models EAMC1000-05, WAFB208-02) due to risk that a Medline syringe rotating adapter may unwind during use, causing loose or full disconnection between the syringe and manifold.
Erbe Medical is recalling ERBEFLO CleverCap CO2 hybrid tubing and cap sets used with endoscopes because the distal connector may allow unintended water flow, potentially leading to water aspiration and serious respiratory complications.
Medline is recalling multiple convenience kits used in catheterization labs and surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance. The affected kits were distributed nationwide.
Erbe Medical is recalling ERBEFLO 2 Endoscopy Pump Tubing/Cap Sets due to a connector design that may allow unintended water flow, potentially leading to water aspiration and serious respiratory conditions.
AVID Medical is recalling the Halyard CATH LAB kit (Model SACL75-01) due to risk that a Medline syringe rotating adaptor may unwind during use, causing loose or complete disconnection between the syringe and manifold.
Raw Farm LLC is recalling shredded raw cheddar cheese (80 oz, UPC 835204000194) due to a multi-state E. coli O157:H7 outbreak. The affected product was distributed across ten U.S. states.
Griffith Foods Inc. is recalling Milk-N-Egg Mix (50-lb bags) due to potential Salmonella contamination in the nonfat dry milk ingredient. The affected product was distributed to 15 states.
Griffith Foods Inc. is recalling 50 oz bags of milk wash packed for Chick-fil-A due to potential Salmonella contamination in the nonfat dry milk ingredient. The product was distributed to 15 states.
Medical Action Industries is recalling Pack Cath BHH catheter kits because the rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Raw Farm LLC is recalling Raw Farm Original Raw Cheddar 80 oz bulk cheese due to a multi-state outbreak of E. coli O157:H7.
Ventec Life Systems is recalling VOCSN V+Pro ventilator units because they may not have been fully tested for high-pressure conditions, which could cause oxygen leaks and increase fire risk during use.
Cook Incorporated is recalling Beacon Tip Centimeter Sizing Catheters because marker bands may crack or break, which could lead to device fragmentation, prolonged procedures, vessel injury, and in worst-case scenarios, life-threatening harm or death.
CareFusion 213, LLC is recalling BD PurPrep (povidone-iodine 8.3% with isopropyl alcohol 72.5%) due to lack of assurance of sterility and potential product contamination. Affected lots are distributed nationwide.
B. Braun Medical Inc. is recalling Lactated Ringer's Injection USP (1000 mL containers) due to the presence of particulate matter. The recall affects 95,412 containers distributed nationwide.
Medline Industries is recalling six models of medical device convenience kits due to calibration issues with sterilization and packaging equipment that may have reduced sterility assurance levels. The recall affects 553 units distributed nationwide.
The Halyard PERC TRAY kit (models SLPC34-01 and SLPC34-02) is being recalled due to risk that a Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Medline Industries is recalling approximately 29,192 labor and delivery kits and OB packs due to calibration issues in sterilization equipment that may impact sterility assurance. The products were exposed to validated sterilization cycles, but the calibration problems potentially compromise sterile status.
California Dairies Inc. is recalling Low Heat Non-Fat Dried Milk Powder in 25 kg paper bags due to potential Salmonella contamination. The product was distributed domestically and to Mexico, Philippines, and Dominican Republic.
Raw Farm Raw Cheddar cheese in 8 oz and 16 oz packages is recalled due to a multi-state E. coli O157:H7 outbreak. Affected products were distributed in nine U.S. states.
Givaudan Flavors Corp is recalling Bulk WN-976-782-1 Seasoning for Cheese Sauce due to potential Salmonella contamination. The affected product is a 43.50 lb. bulk seasoning in a brown kraft bag.
Raw Farm LLC is recalling Raw Cheddar Jalapeno cheese due to a multi-state outbreak of E. coli O157:H7. The affected cheese was distributed across multiple U.S. states.
Raw Farm is recalling Raw Cheddar Simply Shredded cheese due to a multi-state outbreak of E. coli O157:H7. The affected product was distributed across multiple U.S. states.
CareFusion 213, LLC is recalling PurPrep sterile topical solution due to lack of assurance of sterility and potential product contamination. The affected product is a povidone-iodine and isopropyl alcohol solution distributed nationwide.
AVID Medical is recalling the Halyard HEART CATH SELF REGIONAL kit (Model SELF131-05) because the Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.