Colpassist Vaginal Positioning Device — Class II medical device recall Z-1490-2021
Ongoing recall by Boston Scientific Corporation, reported 2021-05-05, distributed nationwide. Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-
| Recall number | Z-1490-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2021-04-15 |
| Classified | 2021-04-23 |
| Reported by FDA | 2021-05-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CL, CO, CR, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HK, IT, JO, LB, MA, MX, NL, NO, NZ, PA, PL, PT, RS, SE, SI, SK, TW, ZA |
| Quantity | 4,549 ww |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 08714729848097 |
| Lot numbers | C003699, C003715, C003735, C003750, C003775, C003804, C003813, C003842, C003853, C003887, C003905, C003936, C003950, C003960, C003966, C003986, C003997, C004028, C004041, C004078, C004091, C004107, C004117, C004128, C004136, C004160, C004186, C004206, C004221 |
Product
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210
Reason for recall
Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
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-1490-2021. 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.