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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Terminated Recall

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
07/08/2020	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 …

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