Data Foundry

Medical device recalls 2018

Uphold LITE w/ Capio SLIM — Class II medical device recall Z-1622-2018

Terminated recall by Boston Scientific Corporation, reported 2018-05-16, distributed in GA. Potential for Capio sutures to break and /or detach.

Recall numberZ-1622-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBoston Scientific Corporation, Marlborough, MA, United States
Recall initiated2018-02-12
Classified2018-05-04
Reported by FDA2018-05-16
Terminated2020-04-10
DistributedGA
Countries outside the USAE, 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
Quantity24,126
Reason classesdevice malfunction
UPC / GTIN / UDI-DI08714729839200
Lot numbers21250249, 21271669, 21336724, 21377535, 21402115, 21432026, 21447170, 21496403, 27019, 27898, 28713, 28974, 29299, 30503, 31359, 31516, 32828, 32829, 33791, 33792, 34053, 36070, 37918, 39009, 39700, 56827, 56829, 57715, 57716, 58081, 58083, 58944, 58945, 60407, 60409, 61098, 61420, 61421, 61422, 61425 and 11 more
Model numbersM0068318170

Product

Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.

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-1622-2018. 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.