Ethicon Echelon Flex Powered Plus Stapler Recalled for Anvil Defect
Ethicon Endo-Surgery Inc is recalling 2,112 Echelon Flex Powered Plus ENDOPATH 60mm Staplers worldwide 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly lists 'death' as a potential risk resulting from the compromised staple line integrity, which mandates a Critical severity score per the rubric.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 2,112 units of the ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft (Product Code PSEE60A). The recall affects specific lots distributed worldwide, including the United States, Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.
The recall was initiated 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.
The affected lot numbers are T93Z5W, T93Z5X, T9405V, T9405W, T93Z3F, T9401L, T93Y8X, T94008, T9400D, and T93Z5R. Healthcare providers and facilities should check their inventory for these specific product codes and lot numbers and stop using the affected devices.
The recalled product
- Product
- ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 2,112
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 (10)
- Lot: T93Z5W
- T93Z5X
- T9405V
- T9405W
- T93Z3F
- T9401L
- T93Y8X
- T94008
- T9400D
- T93Z5R
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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