Encore — Class II medical device recall Z-3043-2017
Terminated recall by Boston Scientific Corporation, reported 2017-08-23. Boston Scientific (BSC) has received complaints for cracked trays on the Encore device.
| Recall number | Z-3043-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2017-06-15 |
| Classified | 2017-08-16 |
| Reported by FDA | 2017-08-23 |
| Terminated | 2020-07-22 |
| Quantity | 305,779 units |
| Reason classes | packaging |
| Serial numbers | 19563006, 19587644, 19594194, 19623019, 19623142, 19640750, 19650458, 19667072, 19704550, 19704551, 19717352, 19725489, 19755302, 19755304, 19755307, 19769215, 19785021, 19808180, 19808183, 20030825, 20054530, 20056496, 20060033, 20077271, 20083051 and 43 more |
Product
Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140
Reason for recall
Boston Scientific (BSC) has received complaints for cracked trays on the Encore 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-3043-2017. 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.