EXALT Model D Single-Use Duodenoscope — Class II medical device recall Z-1082-2022
Ongoing recall by Boston Scientific Corporation, reported 2022-05-25, distributed nationwide. Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perfo
| Recall number | Z-1082-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2022-03-03 |
| Classified | 2022-05-13 |
| Reported by FDA | 2022-05-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, CA, CH, CN, CZ, DE, DK, EG, ES, FR, GB, GR, HK, HU, IE, IL, IN, IT, KW, NL, NO, OM, PL, PT, QA, SA, SE, SK, TW, ZA |
| Quantity | 538 units |
| UPC / GTIN / UDI-DI | 08714729995753 |
Product
EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.
Reason for recall
Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
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-1082-2022. 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.