EXALT Controller — Class III medical device recall Z-1492-2021
Terminated recall by Boston Scientific Corporation, reported 2021-05-05, distributed nationwide. May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
| Recall number | Z-1492-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2021-03-16 |
| Classified | 2021-04-26 |
| Reported by FDA | 2021-05-05 |
| Terminated | 2022-05-02 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| UPC / GTIN / UDI-DI | 08714729990901 |
| Serial numbers | 2005201213, 2005201287, 2005201346 |
Product
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
Reason for recall
May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
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-1492-2021. 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.