Capio Standard Box 4 — Class II medical device recall Z-1620-2018
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-1620-2018 |
|---|---|
| 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 | 4,144 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 08714729257622 |
| Lot numbers | 17817547, 17925410, 18139200, 18363737, 18615714, 18826587, 18955689, 19050231, 19225758, 19335465, 19437994, 19698427, 19983956, 20341449, 20639026, 20717524, 21081753, 21258781, 21386211 |
| Model numbers | M0068312321 |
Product
Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
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-1620-2018. 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.