Ethicon Intraluminal Staplers Recalled for Insufficient Firing Stroke
Ethicon Endo-Surgery is recalling 434,614 Straight Intraluminal Staplers (Model SDH21A) 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 metadata explicitly identifies the agency classification as 'Class I'. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical) regardless of other factors, as it indicates a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 434,614 units of Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A. The recall covers all lots with expiration dates ranging from February 2023 to March 2024. The affected products were distributed worldwide, including nationwide in the United States and in numerous other countries such as Canada, Japan, and various nations in Europe, Asia, and the Americas.
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. The agency has classified this recall as Class I, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
Healthcare providers and facilities that have received these devices should stop using them immediately and contact Ethicon Endo-Surgery Inc for further instructions on how to return or dispose of the affected units. Patients who have had these staplers used during a procedure should consult their healthcare provider if they have concerns about their surgical outcome.
The recalled product
- Product
- Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A 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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