EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
Reported: July 13, 2022 Initiated: May 13, 2022 #Z-1322-2022
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.
Details
- Recalling Firm
- Covidien, LP
- Units Affected
- 433,560
- Distribution
- Worldwide distribution - US Nationwide.
- Location
- North Haven, CT
Frequently Asked Questions
What product was recalled? ▼
EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.. Recalled by Covidien, LP. Units affected: 433,560.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 13, 2022. Severity: Moderate. Recall number: Z-1322-2022.
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