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Update on Ethicon Manual Circular Stapler Recall

Update on Ethicon Manual Circular Stapler Recall | ASCRS

As many of you may know, on April 11, 2019, Ethicon notified all U.S. customers they were initiating a voluntary recall of specific lots of Ethicon manual circular staplers, Intraluminal Stapler (ILS). This decision was based on an increase in the rare occurrence of the device having insufficient firing stroke to break the washer and completely form staples. This recall does not impact any of Ethicon’s other surgical staplers or other products. 

The U.S. FDA classified the ILS Proximate Circular Stapler recall as Class I on May 15, 2019. The FDA has confirmed its alignment of Ethicon’s approach in handling this recall.

Ethicon has assured us their top priority is to return supply of this critical product.  They expect to start shipping product during early June.  Additionally, Ethicon is increasing production of their ECHELON CIRCULAR™ Powered Staplers to help reduce the impact of limited overall supply of circular staplers in the market.

The safety of our patients is a priority for both ASCRS and Ethicon. We will continue to inform you of updates on this issue.