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Open, Classified

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

FDA Recall Z-1322-2022 · Posted None

Recalling FirmCovidien, LP
Recall StatusOpen, Classified
Product CodeGAG
Date Initiated2022-05-13
Product Quantity433,560

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.

Firm Action

Beginning 13-MAY-2022 communications to all affected consignees began. In the United States notifications are set via UPS 2-day delivery. Customers should return all unused affected product in inventory to Medtronic. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been transferred. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification.

Root Cause

Process change control

Distribution Pattern

Worldwide distribution - US Nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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