CLASS II Device recall · Reported 25 Aug 2021 · FDA Enforcement Report
Echelon Flex Powered Plus Stapler-intended for transection recalled
Ethicon Endo-Surgery is recalling Echelon Flex Powered Plus Stapler-intended for transection, resection, and/or creation of, distributed nationwide in the US. The recall was initiated on 3 Jun 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2326-2021
- FDA event ID
- 88349
- Recalling firm
- Ethicon Endo-Surgery, Blue Ash, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jun 2021
- FDA classified
- 19 Aug 2021
- Reported
- 25 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Surgical Instruments
Timeline
| 3 Jun 2021 | Recall initiated by company | |
| 19 Aug 2021 | Classified by FDA | +77 days |
| 25 Aug 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mislabeled: Labeled on the package as 60mm contains 45mm devices
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Is Echelon Flex Powered Plus Stapler-intended for transection, resection, and/or creation of recalled?
Yes. Ethicon Endo-Surgery recalled Echelon Flex Powered Plus Stapler-intended for transection, resection, and/or creation of on 3 Jun 2021. The recall is Class II and its status is Terminated. Recall number Z-2326-2021.
Why was it recalled?
Mislabeled: Labeled on the package as 60mm contains 45mm devices
Which lots are affected?
Lot U94V47 Exp Date: July 31, 2023 GTIN: 10705036014607
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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