Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke
Ethicon Endo-Surgery is recalling Curved Intraluminal Staplers, Model CDH25A, 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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. 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 Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A. The recall involves 434,614 units distributed worldwide, including the United States and numerous other countries. The affected lots have expiration dates ranging from December 2022 to March 2024.
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 anastomosis.
Healthcare providers and facilities should stop using the affected devices and contact Ethicon Endo-Surgery for further instructions on return or replacement.
The recalled product
- Product
- Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A 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: December 2022 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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