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[Recalled] EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535. — The affected staplers have the potential for the staple guide to not be securel… | FDA 2022-05-13

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductEEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
Brand / manufacturerCovidien, LP
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1322-2022
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date13 May 2022
EAN / barcode10884523004731

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Covidien, LP

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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