The Recall Desk
HighFDA (Devices)·Z-2326-2021·Announced 2021-08-25

Surgical stapler mislabeled with incorrect device size

Ethicon is recalling ECHELON FLEX Powered Plus Staplers because the product packaging is mislabeled; packages labeled as 60mm contain 45mm devices, which could affect surgical outcomes if the incorrect size is used.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a surgical device with a mislabeling hazard. While no injuries or illnesses have been reported, the use of an incorrectly sized surgical stapling device constitutes a risk-of-harm situation that could affect surgical outcomes, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Ethicon Endo-Surgery Inc. is recalling the ECHELON FLEX Powered Plus Stapler (Product Code: PSEE60A), a surgical stapling device used in open and minimally invasive procedures, including general, gynecologic, urologic, thoracic, and pediatric surgeries.

The recall is due to mislabeling: packages labeled as 60mm devices contain 45mm devices. This discrepancy could result in a surgeon selecting and using an incorrectly sized device during surgical procedures, potentially affecting surgical outcomes.

The recall involves 763 units of Lot U94V47, which has an expiration date of July 31, 2023. These devices were distributed worldwide, including in the US states of Maryland and Washington, and in Belgium, China, Denmark, Estonia, France, Germany, Italy, Japan, Korea, Latvia, Lithuania, Netherlands, Poland, Portugal, Russia, Spain, Sweden, Switzerland, and the United Kingdom.

Healthcare facilities that received affected units should identify and verify the actual device size before use to ensure the correct device is selected for the intended surgical procedure.

The recalled product

Product
ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A
Manufacturer
Ethicon Endo-Surgery Inc
Category
Medical Device — Surgical Stapler
Hazard
  • mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot U94V47 Exp Date: July 31
  • 2023 GTIN: 10705036014607

Distribution

Distributed nationwide across the United States.

Related recalls

Same category