Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK… — Class II medical device recall Z-0844-2024
Ongoing recall by Covidien LP, reported 2024-02-07, distributed nationwide. Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma le
| Recall number | Z-0844-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LP, Mansfield, MA, United States |
| Recall initiated | 2023-12-21 |
| Classified | 2024-01-29 |
| Reported by FDA | 2024-02-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BG, BH, CH, CN, CY, CZ, DE, ES, FI, FR, GB, GR, HK, HU, IT, JP, KR, NL, NZ, PA, PL, PT, SE, SG, SK, TH, TW, ZA |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 10884521071728, 10884521071742, 10884521071766, 20884521071725, 20884521071749, 20884521071763, 20884521071794 |
| Lot numbers | D1L1929RY, D1M0640RY, D1M1494RY, D2B0176RY, D2B2243RY, D2D2437RY, D2E0905RY, D2E0916RY |
| Model numbers | 2-0BLK, 3-0BLK, 4-0BLK, 7X75CMPCT, 88861919-31, 88861919-41, 88861919-51, 88861919-71 |
Product
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT
Reason for recall
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0844-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.