Endopath Echelon 45mm Reloads with Gripping Surface recall
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface…
Why was Endopath Echelon 45mm Reloads with Gripping Surface recalled?
There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI-DI 10705036014928 Lots 442C02 and 442C03
- Product
- ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface…
- Recalling firm
- Ethicon Endo-Surgery Inc
- Quantity
- 22,616 (US), 4,476 (OUS)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Brazil.
- Recall date
- February 7, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)