Z-2326-2021Class II

ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The...

Name: Z-2326-2021 ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The...
Creator: Ethicon Endo-Surgery Inc
Published: 2021-06-03
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2021-06-03 / Terminated / root cause: packaging

FDA source

Ethicon Endo-Surgery Inc began a recall of ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or... on 2021-06-03. FDA classified it as Class II and gives the reason as "Mislabeled: Labeled on the package as 60mm contains 45mm devices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2326-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-03
Posted: 2021-08-19
Terminated: 2022-09-14
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
Product code: GDW Staple, Implantable
Reason for recall: Mislabeled: Labeled on the package as 60mm contains 45mm devices
Root cause tag: packaging
FDA 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 [email protected] within three (3) business days. To request a copy of the BRF that may be completed and signed electronically, please email [email protected]. 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 in commerce: 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.
Product codes and lots: Lot U94V47 Exp Date: July 31, 2023 GTIN: 10705036014607

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2326-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2326-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-25	2021-08-19

Product code GDW

K202665Class IIEchelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mmEthicon Endo-Surgery, LLC / cleared 2020-10-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)