Syneture

Covidien LP · Model US1666 · UDI-DI 10884521189591

OVN Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Custom Suture Pack,(1) 88863256-41;(2) 88863271-41;(2) 88866307-71;(1) CS-9-M;(1) GL-122;(1) S-183;(1) S-185;(1) S-317;(2) SM-5637;(1) SS-678;(1) SS-70-M;(1) UL-215;(1) VP-522-X;(1) VP-558-X;(3) VP-702-X;(3) VP-706-X;(1) VP-745-X

Recalls

Date	Firm	Reason
2026-03-09	LSL Healthcare Inc.	Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
2025-12-12	Medline Industries, LP	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the via
2024-04-08	MEDLINE INDUSTRIES, LP - Northfield	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2014-06-12	Medical Action Industries Inc	Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12	Medical Action Industries Inc	Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12	Medical Action Industries Inc	Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12	Medical Action Industries Inc	Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12	Medical Action Industries Inc	Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12	Medical Action Industries Inc	Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12	Medical Action Industries Inc	Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

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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.