RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321… — Class II medical device recall Z-0780-2022
Ongoing recall by Boston Scientific Corporation, reported 2022-03-23, distributed nationwide. Sterility of device is compromised due to a sterile barrier breach
| Recall number | Z-0780-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2021-12-22 |
| Classified | 2022-03-11 |
| Reported by FDA | 2022-03-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, IE, IT, JP, KR, KW, LB, LV, MA, NL, NO, NZ, PL, PT, QA, RO, SA, SE, SI, SK, ZA |
| Quantity | 500 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 08714729818380, 08714729818410, 08714729818427, 08714729818458, 08714729818465, 08714729818472, 08714729818489, 08714729818496 |
| Lot numbers | 27673853, 27755939, 27803953, 27878151, 27891176, 27919775, 27919776, 27955111, 27990502, 28024443, 28024444, 28060354, 28074763, 28103331, 28269925, 28311945, 28336117, M00575241RX |
Product
RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
Reason for recall
Sterility of device is compromised due to a sterile barrier breach
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-0780-2022. 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.