Surgilon Braided Nylon suture Product Description: 88861883-51… — Class II medical device recall Z-1178-2023
Ongoing recall by Covidien, LP, reported 2023-03-08, distributed nationwide. Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases
| Recall number | Z-1178-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2022-12-02 |
| Classified | 2023-02-25 |
| Reported by FDA | 2023-03-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LT, LV, MA, MT, MX, MY, NL, NO, NZ, PA, PH, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VN, ZA |
| Quantity | 87,708 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10884521071223, 10884521071513, 10884521071766, 10884521071797, 10884521072183, 10884521073838, 10884521076662, 20884521071220, 20884521071510, 20884521071725, 20884521071749, 20884521071763, 20884521071787, 20884521071794, 20884521072180, 20884521073835, 20884521073996, 20884521076652, 20884521076669 |
| Lot numbers | 8886188351, 8886191571, 8886191931, 8886191941, 8886191951, 8886191961, 8886191971, 8886193251, 8886197171, 8886198571, D1E0626Y, D1E1212FY, D1G1867Y, D1K1677FY, D1M0640Y, D1M0915Y, D1M1423Y, D1M1494Y, D1M2553Y, D1M2561Y, D2A0560Y, D2A0861Y, D2A0865Y, D2A1709Y, D2B0169Y, D2B0290Y, D2B0445Y, D2B0476Y, D2B0707FY, D2B1245Y, D2B1349Y, D2B1350Y, D2B1537Y, D2B2243Y, D2B2727Y, D2B2751Y, D2C0267Y, D2C0907Y, D2C0962Y, D2C1101Y and 9 more |
| Model numbers | 8886188351, 8886191571, 8886191931, 8886191941, 8886191951, 8886191961, 8886191971, 8886193251, 8886197171, 8886198571, D1E0626Y, D1E1212FY, D1G1867Y, D1K1677FY, D1M0640Y, D1M0915Y, D1M1423Y, D1M1494Y, D1M2553Y, D1M2561Y, D2A0560Y, D2A0861Y, D2A0865Y, D2A1709Y, D2B0169Y and 24 more |
Product
Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0 BLK 7X75CM PCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT 88861932-51 SURGILON* 2-0 BLK 75CM GS10 88861971-71 SURGILON* 1 BLK 75CM GS21 88861985-71 SURGILON* 1 BLK 75CM SC1X36 SBS-1884G SURGILON* 4-0 WHI 45CM P12X12 SBS-1928G SURGILON* 5-0 BLK 45CM P13X12
Reason for recall
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
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-1178-2023. 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.