Z-0201-2020Class I

ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A

Name: Z-0201-2020 ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
Creator: Ethicon Endo-Surgery Inc
Published: 2019-10-03
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2019-10-03 / Terminated / root cause: manufacturing process

FDA source

Ethicon Endo-Surgery Inc began a recall of ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A on 2019-10-03. FDA classified it as Class I and gives the reason as "The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0201-2020
Classification: Class I
Status: Terminated
Initiated: 2019-10-03
Posted: 2019-10-29
Terminated: 2021-06-03
Recalling firm: Ethicon Endo-Surgery Inc
Product: ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
Product code: GDW Staple, Implantable
Reason for recall: The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Urgent Medical Device Recall (Removal) letters were sent to customers beginning 10/3/19. The letters instruct customers to do the following: ACTION REQUIRED: 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 voluntary 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 recall 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 fax or email it to Stericycle at 1-866-300-3432 or [email protected] within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 5. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Stericycle. 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. 6. Customers are required to return unused impacted ECHELON FLEX ENDOPATH 60mm Staplers subject to this recall that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall by December 31, 2019. Any nonaffected product and any product returned after the date specified will not be replaced. 7. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling Stericycle at 1-866-918-8756. Your account n
Quantity in commerce: 255 units
Distribution: Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.
Product codes and lots: Lot: T93Z9Y, T9411A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0201-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0200-2020	Class I	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29
Z-0201-2020	Class I	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29
Z-0202-2020	Class I	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29
Z-0203-2020	Class I	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29

Product code GDW

K160521Class IIECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmEthicon Endo-Surgery, LLC / cleared 2016-03-22

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)