Ethicon Endo-Surgery Recalls Straight Intraluminal Staplers Due to Firing Defect
Ethicon Endo-Surgery Inc is recalling 434,614 Straight Intraluminal Staplers (Model SDH25A) because they may have an insufficient firing stroke to break the washer and completely form staples.
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 recall is classified as FDA Class I, which the rubric mandates a minimum score of 4 (Severe). Additionally, the defect involves a structural failure of a medical device used in surgery, posing a significant risk of injury.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 434,614 units of Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A. These anastomotic staplers are used 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 potentially affect the integrity of the surgical procedure.
The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries such as Argentina, Canada, China, India, Japan, and Mexico. The recall covers all lots with expiration dates ranging from February 2023 to March 2024. Healthcare providers and facilities should stop using these devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A 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 to the…
- 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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