FDA Device Intelligence
HomeCovidien LP › Auto Suture

Auto Suture

Covidien LP · Model 1011 · UDI-DI 10884521066397

FEB Prescription
1
510(k) clearances
5,072
Adverse events (22 deaths)
40
Recalls
22
Facilities

Description

Anti-Fog Kit

Recalls

DateFirmReason
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasPotential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25Olympus Corporation of the AmericasXXX

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.