Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke
Ethicon Endo-Surgery Inc is recalling 434,614 Curved Intraluminal Staplers (Model CDH29A) because they may have an insufficient firing stroke to break the washer and completely form staples.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (insufficient firing stroke) that could lead to improper staple formation. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 434,614 units of Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A. The recall covers all lots with expiration dates ranging from December 2022 to March 2024. The product was distributed nationwide in the United States and in numerous countries worldwide, including Argentina, Canada, China, India, Japan, and Mexico.
The recall was initiated because the staplers may have an insufficient firing stroke to break the washer and completely form staples. The Ethicon Endo-Surgery Intraluminal Staplers are anastomotic staplers 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 source text does not specify specific actions for consumers or healthcare providers, nor does it report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A 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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