Capio CL — Class II medical device recall Z-1618-2018
Terminated recall by Boston Scientific Corporation, reported 2018-05-16, distributed in GA. Potential for Capio sutures to break and /or detach.
| Recall number | Z-1618-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2018-02-12 |
| Classified | 2018-05-04 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2020-04-10 |
| Distributed | GA |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CO, CR, CZ, DE, DK, DO, EC, EG, ES, FI, FR, GB, GR, GT, HK, HN, IE, IL, IR, IS, IT, JO, JP, KE, KW, LB, MT, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PK, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, SV, TR, TT, TW, VE, ZA |
| Quantity | 1,258 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 08714729516545 |
| Lot numbers | 18011270, 18011271, 18229999, 18245411, 18654941, 18881759, 19173286, 19491588, 19668541, 19987267, 20382965, 20602764, 20850569, 21234964 |
| Model numbers | M0068311350 |
Product
Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.
Reason for recall
Potential for Capio sutures to break and /or detach.
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-1618-2018. 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.