Recall Z-1322-2022— Covidien, LP

Name: FDA recall Z-1322-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-13

Class II · Ongoing

Class II FDA medical device recall by Covidien, LP, initiated 2022-05-13. FDA's recall record names no specific 510(k) clearance for this event. Product: EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.. Reason: 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..

Recalling firm: Covidien, LP
Classification: Class II
Status: Ongoing
Initiated: 2022-05-13
Firm location: North Haven, CT, United States

Product description

EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.