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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| 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 … |