[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
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535. |
|---|---|
| Brand / manufacturer | Covidien, LP |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1322-2022 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 13 May 2022 |
| EAN / barcode | 10884523004731 |
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.