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Syneture

Covidien LP · Model US1490 · UDI-DI 10884521160576

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

Description

(2) 88863256-51;(2) CL-842;(2) CL-954;(2) GS-62-M;(4) GS-834;(1) S-194;(1) S-195;(2) S-608;(4) SL-5637;(2) SS-685;(2) VP-521-X;(2) VP-522-X;(2) VP-557-X;(2) VP-706-X;(2) VP-726-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.