Ethicon ECHELON FLEX Powered Plus Stapler Recalled: Mislabeled Size
Ethicon recalls ECHELON FLEX Powered Plus Stapler devices labeled as 60mm but containing 45mm devices. This mislabeling may cause surgical errors. Affected units have specific product codes and expiration dates.
Lower-risk recall
Mislabeled: Labeled on the package as 60mm contains 45mm devices
Contact the company
What happened, in plain English
Ethicon is recalling ECHELON FLEX Powered Plus Stapler surgical devices because they are mislabeled as 60mm but actually contain 45mm devices. This could lead to surgical errors if used without proper size awareness. Read more at govinfonow.com/recall/62419-ethicon-echelon-flex-powered-plus-stapler-recalled-mislabeled-size.
Source Summary by GovInfoNow · govinfonow.com/recall/62419-ethicon-echelon-flex-powered-plus-stapler-recalled-mislabeled-size · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2326-2021
Cite this page
“Ethicon ECHELON FLEX Powered Plus Stapler Recalled: Mislabeled Size.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62419-ethicon-echelon-flex-powered-plus-stapler-recalled-mislabeled-size. Based on FDA recall #Z-2326-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2326-2021%22&limit=1).
Why it’s dangerous
The devices are labeled as 60mm but contain 45mm devices. This size discrepancy could lead to improper surgical technique if the surgeon uses the device without verifying the actual size, potentially causing tissue damage or surgical errors.
Who’s affected
Surgical professionals using the ECHELON FLEX Powered Plus Stapler for procedures like resection or anastomosis. Patients undergoing surgery with this device may be at risk if the mislabeled size causes incorrect application.
How to tell if you have this one
Check for product code PSEE60A, lot number U94V47, and expiration date July 31, 2023. The devices are sold under GTIN 10705036014607.
- Brand
Ethicon- Product
ECHELON FLEX Powered Plus Stapler- Category
Medical device
What to do — step by step
Check Device Label
Look for the product code PSEE60A, lot number U94V47, and expiration date July 31, 2023 on the device packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Maryland, Washington.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury?
The recall is for mislabeling, not a safety hazard that causes injury. The risk is low and related to potential surgical errors.
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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-2326-2021 (June 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2326-2021 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.