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 |
|---|---|---|---|---|---|---|---|
| B. Braun | Lactated Ringer’s Injection USP 1000 mL/0.9% Sodium Chloride Injection USP 1000 mL | Drugs | Due to the presence of particulate matter. | B. Braun Medical, Inc. | … key product areas include nutrition, pharmacy admixture and dialysis. The company is committed to eliminating … | ||
| 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. | Terminated | … with an event 0.88% (112/12763) 0.65% (47/7285) 1 Includes dialysis, prolonged cardiac support, or liver failure; 2 … |