Recall Z-2281-2026— Covidien, LP

Name: FDA recall Z-2281-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-15

Class II · Ongoing

Class II FDA medical device recall by Covidien, LP, initiated 2026-04-15. It names one FDA 510(k) clearance: K934738. Product: Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;. Reason: The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure..

Recalling firm: Covidien, LP
Classification: Class II
Status: Ongoing
Initiated: 2026-04-15
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K934738 — AUTOSUTURE ENDOSCOPIC SUTURING DEVICEUnited States Surgical, A Division of Tyco Healthc·cleared 1994-03-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;

Reason for recall

The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.

Data sourced from openFDA. This site is unofficial and independent of the FDA.