EEA Autosuture Circular Staplers Recalled for Staple Guide Detachment Risk
Covidien is recalling EEA Autosuture Circular Staplers (25mm) because the staple guide may not be securely attached and could disengage during use, potentially allowing the device to cut tissue without forming staples.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: FDA Class II recall with a serious potential hazard—the staple guide may disengage, allowing unintended tissue transection. No illnesses or injuries are reported in the source; per the rubric, when no illnesses/injuries are documented and the hazard is theoretical, the score is at most 3.
Plain-English summary
Covidien, LP is recalling EEA Autosuture Circular Staplers with DST Series Technology in 25mm size. The recall involves model numbers EEA25, EEAXL25, EEA2535, and EEAXL2535. Approximately 433,560 units have been distributed in the United States and worldwide.
The staple guide on affected devices may not be securely attached to the instrument. If this component disengages, the device could cut tissue without forming staples.
Healthcare providers and hospitals should identify affected units using their model and lot numbers. Affected devices should be removed from service. For more information, contact Covidien or the FDA using recall number Z-1322-2022.
The recalled product
- Product
- EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
- Manufacturer
- Covidien, LP
- Affected units
- 433,560
Distribution
Distributed nationwide across the United States.
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