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Syneture
Covidien LP · Model US1516 · UDI-DI 10884521160729
OVN
Prescription
0
510(k) clearances
40
Adverse events
10
Recalls
34
Facilities
Description
Custom Suture Pack,(1) 88861926-52;(2) 88861993-52;(4) 88863119-61;(2) CLS-812;(2) CLS-843;(1) GS-833;(1) S-317;(3) SM-5679G;(1) VP-581-X;(1) VP-706-MX;(1) VP-735-MX;(1) VS-889
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.