Use caution Medical device recall · FDA · Published October 3, 2019

Ethicon ECHELON FLEX ENDOPATH 60mm Stapler Recall: Risk of Compromised Staples

Ethicon recalls ECHELON FLEX ENDOPATH 60mm staplers with specific product codes due to potential staple line failure causing surgery complications. Affected units may require replacement to prevent serious risks.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0200-2020Medical device Ethicon ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmEthicon Endo-Surgery Inc4545 Creek Rd · Blue Ash, OH 45242-2803

✎ GovInfoNow plain-language explainer

Ethicon is recalling certain ECHELON FLEX ENDOPATH 60mm staplers that may have faulty anvil components. This could lead to weakened staples that might cause bleeding, infections, or surgery complications if not properly sealed. Read more at govinfonow.com/recall/66904-ethicon-echelon-flex-endopath-60mm-stapler-recall-risk-of-compromised.

Source Summary by GovInfoNow · govinfonow.com/recall/66904-ethicon-echelon-flex-endopath-60mm-stapler-recall-risk-of-compromised · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0200-2020

Cite this page

“Ethicon ECHELON FLEX ENDOPATH 60mm Stapler Recall: Risk of Compromised Staples.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66904-ethicon-echelon-flex-endopath-60mm-stapler-recall-risk-of-compromised. Based on FDA recall #Z-0200-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0200-2020%22&limit=1).

The FDA announced on 2019-10-03 that Ethicon Endo-Surgery Inc voluntarily recalled ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft (Product Code EC60A) due to a potential out-of-specification anvil component. This defect may lead to malformed staples and compromise staple line integrity, posing risks of hemorrhage or death.

How to tell if you have it

Brand: Ethicon
Product: ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft
Product Code: EC60A
Lot Codes: T9408M, T94899, T94A9Z
Units Affected: 849

The hazard

According to the FDA, 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.

Context

GovInfoNow's records show Ethicon Endo-Surgery Inc has had 12 other recalls on record since 2017-10-23. Recent similar recalls include the Ethicon ECHELON LINEAR Cutters Reload 80mm Blue recall dated 2025-09-11 and the Ethicon Endopath Echelon Vascular White Reload recall dated 2025-04-22. Other recent recalls of similar products include the Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (2026-03-03), the Intuitive 8 mm SureForm 30 Gray Reloads recall (2026-03-11), and the Covidien V-Loc 180 Absorbable Wound Closure Device Recall (2026-06-24).

How to tell if you have this one

Check for product code EC60A on the stapler. Affected units were sold with lot numbers T9408M, T94899, or T94A9Z.

Brand
Ethicon
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Terminated
Distribution
Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.

Recall number	Product, codes & lots	Quantity
Z-0200-2020	ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A; Lot: T9408M, T94899, T94A9Z	849 units
Z-0201-2020	ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A; Lot: T93Z9Y, T9411A	255 units
Z-0202-2020	ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A; Lot: T93Z1G, T93Y4M, T94045, T94117, T93X17, T94087, T93Z2X, T9405L, T94253, T93X95, T93Z75, T93Z2W, T9413Z	5040 units
Z-0203-2020	ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A; Lot: T93Z5W, T93Z5X, T9405V, T9405W, T93Z3F, T9401L, T93Y8X, T94008, T9400D, T93Z5R	2112 units

Based on the official FDA remedy

What to do — step by step

Check Product Code
Look for the product code EC60A on the stapler to confirm if it's affected.
Contact Manufacturer
Reach out to Ethicon Endo-Surgery Inc for guidance on next steps if the product is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

Oct 3, 2019Firm started the recall
Oct 29, 2019FDA classified it Class I
Nov 6, 2019Published in FDA’s Enforcement Report
Jun 3, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/66904-ethicon-echelon-flex-endopath-60mm-stapler-recall-risk-of-compromised">Ethicon ECHELON FLEX ENDOPATH 60mm Stapler Recall: Risk of Compromised Staples (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0200-2020 (October 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0200-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.