On May 16, 2019, the U.S. Food and Drug Administration (FDA) initiated a recall of Ethicon surgical staplers. The recall affected tens of thousands of Endo-Surgery Endoscopic Curved Intraluminal Staplers and Endo-Surgery Curved Intraluminal Staplers in circulation that were found to be unsafe.
The Ethicon stapler recall was initiated for 92,496 intraluminal staplers manufactured and distributed from Mar. 6, 2016, until May 8, 2019, after it was discovered that the units were ejecting malformed staples which compromised the integrity of the staple line used to seal the patient’s wound. The FDA has informed physicians that use of units affected by the Ethicon stapler recall could result in:
- Bacterial infection
- Anastomotic leaks in the closure
- The need for a permanent ostomy bag
- Life-long nutritional and digestive issues
- Need for additional surgeries
- Need for additional closures
In response to the risk posed by Ethicon’s intraluminal stapler units, the FDA has requested that physicians use manual staplers from other manufacturers, hand sew the wound closed, delay surgeries where units affected by the Ethicon stapler recall may be used or attempt to perform minimally invasive procedures.
Ethicon has acknowledged their part in the recall by requesting that all Ethicon clients examine their inventory for any product marked by the FDA recall as defective. Additionally, resellers have been asked to contact any location they may have resold the units to and request they return the product. All defective product has been requested by Ethicon for proper disposal and inventorying.