Endoscopic Surgical Stapler Reload May Fail to Form Complete Staple Line
An endoscopic surgical stapler reload may fail to properly form staples during use, potentially leaving tissue inadequately sealed. This could lead to bleeding or require additional surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II designation with potential for serious surgical complications including incomplete stapling, bleeding, and need for additional surgical intervention. No illnesses or injuries are reported in the source text, but the risk of harm during surgery is significant.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling specific lots of the ENDOPATH ECHELON 45mm surgical stapler reload with Gripping Surface Technology. These devices are used during endoscopic surgical procedures to cut and staple tissue.
The recalled devices (lots 442C02 and 442C03) may fail to form a complete staple line during the firing sequence, with most or all staples remaining undeployed. This incomplete stapling can result in insufficient closure of the surgical tissue site.
If tissue closure is inadequate, patients may experience bleeding or require additional surgical intervention. The device failure may also prolong surgery or cause surgical delay while the surgeon addresses the incomplete staple line.
The recall affects approximately 22,616 units distributed in the United States and 4,476 units distributed to Canada and Brazil. Health care facilities using these products should contact Ethicon Endo-Surgery Inc for instructions on returning or replacing affected lots.
The recalled product
- Product
- ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
- Manufacturer
- Ethicon Endo-Surgery Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 10705036014928 Lots 442C02 and 442C03
Distribution
Distributed nationwide across the United States.
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