May 16, 2019

FDA: Class I recall of Ethicon circular staplers

By: Judy Mathias
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Editor’s Note

The Food and Drug Administration (FDA) on May 16 identified the recall by Ethicon of its Endo-Surgery and Endo-Surgery Endoscopic Curved Intraluminal Staplers with adjustable height staples as Class I, the most serious.

The recall was initiated because Ethicon confirmed that uncut washers in the staplers and malformed staples have occurred because of insufficient firing, which can compromise staple line integrity. Ethicon confirmed serious injuries in two patients.

Distribution dates were March 6, 2018, to March 8, 2019.

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