Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke
Ethicon Endo-Surgery is recalling 434,614 Curved Intraluminal Staplers (Model CDH33A) because they may have an insufficient firing stroke to break the washer and form staples.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device used for surgical anastomosis that could lead to serious injury or death if the staples do not form completely, meeting the criteria for a Severe (Score 4) classification.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 434,614 units of Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A. The recall covers all lots with expiration dates between December 2022 and March 2024. These devices are anastomotic staplers 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 is being issued 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 affected products were distributed worldwide, including nationwide in the United States and in numerous other countries such as Canada, Japan, and the United Kingdom. Healthcare providers and facilities should stop using these devices and contact Ethicon Endo-Surgery for further instructions.
The recalled product
- Product
- Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A 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 an
- 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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