Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX — Class II medical device recall Z-2922-2026
Ongoing recall by Covidien, LP, reported 2026-08-19, distributed nationwide. Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontam
| Recall number | Z-2922-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2026-06-24 |
| Classified | 2026-08-07 |
| Reported by FDA | 2026-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, CA, CH, CL, CN, CO, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, IE, IL, IN, IS, IT, JP, KR, LB, LT, LU, MX, NL, NO, OM, PA, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, TH, TW, UA, ZA |
| Quantity | 135,875 total |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 20612479214716 |
| Lot numbers | D5M3438FY |
Product
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Reason for recall
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 vision if in ophthalmic utilization, or prolonged surgery.
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-2922-2026. 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.