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 | Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding. |
| Product | SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600 |
| Quantity | 5026 |
| Distribution | Worldwide Distribution US nationwide, Austria, Belarus, Belguim, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, Bahrain, China, Hong Kong, India, Malaysia, Pakistan, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Thailand, Tunisia, Turkey, Vietnam, B… |
| Initiated | 2017-12-20 |
| Classified | 2018-03-19 |
| Terminated | 2019-12-13 |
| Recall number | Z-1133-2018 |
| 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-1133-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79529/
Alerts for Boston Scientific Corporation
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.