Ethicon Endo-Surgery Recalls Endoscopic Curved Intraluminal Staplers
Ethicon Endo-Surgery is recalling 434,614 endoscopic curved intraluminal staplers because they may have an insufficient firing stroke to break the washer and completely form staples.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is 'Class I'. According to the rubric, if the agency's own classification is FDA Class I, the score must be 5 (Critical) regardless of other factors.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 434,614 units of the Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A. The recall covers all lots with expiration dates ranging from February 2023 to March 2024. These anastomotic staplers are designed to permit tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.
The recall was initiated because the staplers may have an insufficient firing stroke to break the washer and completely form staples. This defect could compromise the integrity of the surgical anastomosis. The agency has classified this recall as Class I, which indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The affected products were distributed worldwide, including nationwide in the United States and in numerous international markets such as Canada, Mexico, Brazil, China, India, Japan, and the United Kingdom. Healthcare providers and facilities that have purchased or received these specific staplers should stop using them immediately and contact Ethicon Endo-Surgery for instructions on how to return the devices.
The recalled product
- Product
- Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 434,614
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)
- All Lots within EXPIRATION Date Range: February 2023 March 2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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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