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Syneture
Covidien LP · Model US1550 · UDI-DI 10884521160897
OVN
Prescription
0
510(k) clearances
40
Adverse events
10
Recalls
34
Facilities
Description
Custom Suture Pack,(2) 88863185-51;(4) 88863185-61;(1) 88863229-31;(2) 88863256-41;(2) CL-812;(4) CL-843;(1) GL-323;(1) GS-833;(2) S-183;(1) S-185;(3) S-282;(1) S-305;(3) SL-712;(3) SL-5638;(2) SS-678;(6) VS-890
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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Get your free API keyRead the docsData 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.