EXALT Model D Single-Use Duodenoscope — Class II medical device recall Z-0397-2024
Ongoing recall by Boston Scientific Corporation, reported 2023-11-29, distributed nationwide. Poor image quality due to fluid ingress in the lens.
| Recall number | Z-0397-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2023-09-27 |
| Classified | 2023-11-21 |
| Reported by FDA | 2023-11-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, CZ, DE, DK, ES, FR, GB, IT, NZ, SE |
| UPC / GTIN / UDI-DI | 08714729993605, 08714729995753 |
| Lot numbers | 31118200, 31118201, 31118202, 31129470, 31129503, 31145980, 31150536, 31150537, 31150538, 31175587, 31193809, 31193810, 31232040, 31239963, 31248263, 31251918, 31265893, 31269307, 31275008, 31283026, 31305347, 31322088, 31331654, 31334176, 31338402, 31347461, 31348990, 31357937, 31360721, 31366683, 31373783, 31409362, 31416272, 31424741, 31429697, 31430274, 31440192, 31447120, 31454624, 31458181 and 44 more |
Product
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.
Reason for recall
Poor image quality due to fluid ingress in the lens.
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-0397-2024. 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.