FDA-Device2022-07-13Class II
EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
Covidien, LP
Hazard
The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples.
Sold states
Worldwide distribution - US Nationwide.
Affected count
433,560
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1322-2022Don't want to check this manually?
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