Recall Z-2922-2026— Covidien, LP

Name: FDA recall Z-2922-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-24

Class II · Ongoing

Class II FDA medical device recall by Covidien, LP, initiated 2026-06-24. It names one FDA 510(k) clearance: K050947. Product: Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX. Reason: Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery..

Recalling firm: Covidien, LP
Classification: Class II
Status: Ongoing
Initiated: 2026-06-24
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K050947 — MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTUREUnited States Surgical, A Division of Tyco Healthc·cleared 2005-06-01

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

Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX

Reason for recall

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

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