Ethicon Endo-Surgery Inc: 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

Recall number

Z-2326-2021

Recalling firm

Ethicon Endo-Surgery Inc

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

Status

Terminated

Initiated

2021-06-03

Posted

not on file

Terminated

2022-09-14

Reason

Mislabeled: Labeled on the package as 60mm contains 45mm devices

Root cause

Packaging change control

Action

Ethicon notified US consignees by Urgent Medical Device removal letter on 6/3/21 via Fed-Ex second day. Ethicon Johnson & Johnson Affiliates in impacted countries will notify their customers and health authorities per their local regulations and procedures. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this action has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 4. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and email it to Ethicon at ra-ethus-fa-ss@its.jnj.com within three (3) business days. To request a copy of the BRF that may be completed and signed electronically, please email ra-ethus-fa-ss@its.jnj.com. Please return the BRF even if you do not have product subject to this recall. 5. Follow instructions in the letter and immediately return any inventory of ECHELON FLEX" Powered Plus Stapler, Product Code PSEE60A, Lot U94V47. We request that product subject to this recall be returned no later than September 10, 2021 to Ethicon. Any non-affected product and any product returned after the date specified will not receive replacement. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Ethicon. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records. If you have additional questions regarding this voluntary medical device recall or require any assistance with returning product, please contact the Ethicon Res

Quantity

763 eaches

Distribution

Worldwide distribution - US Nationwide distribution in the states of MD, WA and the countries of Belgium, China, Denmark, Estonia, France, Germany, Italy, Japan, Korea, Latvia, Lithuania, Netherlands, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom.

Lot, serial or model codes

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

510(k) numbers

["K202665"]

PMA numbers

not on file

Product code

GDW

Firm FEI

1527736

Firm city

Blue Ash

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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