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Syneture

Covidien LP · Model US1665 · UDI-DI 10884521189584

OVN Prescription
0
510(k) clearances
40
Adverse events
10
Recalls
34
Facilities

Description

Custom Suture Pack,(2) 88863125-51;(1) 88863251-51;(2) 88866307-71;(1) CS-9-M;(1) S-183;(1) S-185;(1) S-317;(2) SM-5637;(1) SS-678;(1) SS-70-M;(1) UL-215;(3) VP-557-X;(3) VP-702-X;(2) VP-706-X;(1) VP-745-X

Recalls

DateFirmReason
2026-03-09LSL Healthcare Inc.Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
2025-12-12Medline Industries, LPMedline 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
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical 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
2014-06-12Medical Action Industries IncSome of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12Medical Action Industries IncSome of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12Medical Action Industries IncSome of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12Medical Action Industries IncSome of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12Medical Action Industries IncSome of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12Medical Action Industries IncSome of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
2014-06-12Medical Action Industries IncSome 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.