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Recalls, Market Withdrawals, & Safety Alerts

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.

The Recalls, Market Withdrawals & Safety Alerts are available on FDA’s website for three years before being archived. To search archived content, visit Search FDA Archive and input the name of the product and/or company name in the Search terms box as well as the year to get the most inclusive search results. To scroll through archived Recalls, Market Withdrawals & Safety Alerts content by year, see the Recall and Safety Alerts Archive.
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A Terminated Recall is a recall where the FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. Recalls that are not indicated as being terminated are either ongoing or completed.

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 …
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