The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all recalls have press releases or are posted on this page. See Additional information about recalls for a more complete listing.
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|Date||Brand Name(s)||Product Description||Product Type||Recall Reason Description||Company Name||Terminated Recall||Excerpt|
|Arrow||Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR||Medical Devices||Inner lumen may detach from the device’s basket||Teleflex Incorporated||… of native arterio-venous (AV) fistulae and synthetic dialysis grafts. The products involved in the recall are as …|
|Ovation||Ovation iX system||Medical Devices||A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer.||Endologix® Inc.||… with an event 0.88% (112/12763) 0.65% (47/7285) 1 Includes dialysis, prolonged cardiac support, or liver failure; 2 …|
|B. Braun||Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container||Drugs||Out-of-Specification Results for High Molecular Weight Polymers||Braun Medical Inc||Terminated||… key product areas include nutrition, pharmacy admixture and dialysis. The company is committed to eliminating …|
|B. Braun||Blood Administration Kits||Medical Devices||Potential leakage at joint between blood filter and tubing||B. Braun Medical, Inc.||… Other key product areas include ostomy and wound care, dialysis, nutrition, and pharmacy admixture. The company is …|
|Infusomat||Infusion pump||Medical Devices||Potential Leakage||B. Braun Medical Inc.||Terminated||… Other key product areas include ostomy and wound care, dialysis, nutrition, and pharmacy admixture. The company is …|
|Baxter||intravenous (IV) solutions: 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container and 70% Dextrose Injection (2000 mL) USP||Drugs||Labeled as Eliquis5 mg was found to contain Eliquis 2.5 mg tablets||Baxter International Inc.||Terminated||… and may also be used as a priming solution in hemodialysis procedures. 70% Dextrose Injection (2000 mL) USP is … and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and …|