Class II — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential for Capio sutures to break and /or detach. |
| Product | Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in women with pelvic organ prolapse. |
| Quantity | 1,002 |
| Distribution | Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georg… |
| Initiated | 2018-02-12 |
| Classified | 2018-05-04 |
| Terminated | 2020-04-10 |
| Recall number | Z-1626-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Scientific Corporation (Z-1626-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79608/
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