ECHELON FLEX Powered Plus Stapler-intended for recall: Labeling Error
ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple…
Why was ECHELON FLEX Powered Plus Stapler-intended for recalled?
Mislabeled: Labeled on the package as 60mm contains 45mm devices
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot U94V47 Exp Date: July 31, 2023 GTIN: 10705036014607
- Product
- ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple…
- Recalling firm
- Ethicon Endo-Surgery Inc
- Quantity
- 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.
- Recall date
- August 25, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)