Class III — 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 III |
| Status | Terminated |
| Reason | May have been programmed with a less than optimal brightness setting resulting in a darker than desired image |
| Product | EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430 |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of CA, FL, NJ. |
| Initiated | 2021-03-16 |
| Classified | 2021-04-26 |
| Terminated | 2022-05-02 |
| Recall number | Z-1492-2021 |
| 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 III recall — Boston Scientific Corporation (Z-1492-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87593/
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