Ethicon Echelon Flex Endopath Stapler Recall for Out-of-Spec Anvil
Ethicon is recalling Echelon Flex Endopath 60mm Staplers due to out-of-specification anvil components that may compromise staple line integrity.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly lists 'death' as a potential risk resulting from the device defect, which aligns with the rubric criteria for a Severe (4) or Critical (5) rating. Given the agency classification is Class I and the risk includes death, a score of 4 is appropriate as no fatalities are reported in the text.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 849 units of the ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft (Product Code EC60A). The affected lots are T9408M, T94899, and T94A9Z. The recall covers worldwide distribution, including the US, Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.
The recall is issued because the staplers may contain an out-of-specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Healthcare providers and facilities should check their inventory for the specific product code and lot numbers listed above. If the product is found, it should be removed from use and returned to Ethicon Endo-Surgery Inc in accordance with their recall instructions.
The recalled product
- Product
- ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 849
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 (3)
- Lot: T9408M
- T94899
- T94A9Z
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Ethicon Endo-Surgery Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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