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PROLENE
ETHICON, LLC · Model 8656G · UDI-DI 10705031018501
GAW
Prescription
1
510(k) clearances
20,303
Adverse events (226 deaths)
33
Recalls
112
Facilities
Description
Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-17 | Henry Schein Inc. | Products lack 510(k) clearance. |
| 2026-09-17 | Henry Schein Inc. | Products lack 510(k) clearance. |
| 2026-09-17 | Henry Schein Inc. | Products lack 510(k) clearance. |
| 2026-09-17 | Henry Schein Inc. | Products lack 510(k) clearance. |
| 2026-09-17 | Henry Schein Inc. | Products lack 510(k) clearance. |
| 2026-06-24 | Covidien, LP | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v |
| 2026-06-24 | Covidien, LP | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v |
| 2024-12-20 | Ethicon, LLC | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could intr |
| 2024-12-20 | Ethicon, LLC | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could intr |
| 2024-12-20 | Ethicon, LLC | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could intr |
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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.