CRE Wireguided 8-10mm 240cm — Class II medical device recall Z-2633-2026
Ongoing recall by Boston Scientific Corporation, reported 2026-07-08, distributed nationwide. Potential sterile breach of the pouches in which devices are packaged.
| Recall number | Z-2633-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2026-05-21 |
| Classified | 2026-07-01 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BH, CA, CH, CL, CN, CR, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JO, JP, KR, LB, LU, LV, MX, MY, NL, NO, NZ, PE, PH, PK, PL, PT, PY, RO, RS, SE, SG, SI, SK, TN, TT, TW, UY, ZA |
| Quantity | 81,543 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 08714729339397 |
| Lot numbers | 38064055, 38099717, 38100033, 38100034, 38164759, 38165000, 38165003, 38293337, 38293338, 38293339, 38333957, 38347335, 38347336, 38398764, 38398765, 38398766, 38529517, 38552112, 38552113, 38596880, 38680056, 38680057, 38739675 |
| Expiration dates | 2028-10-27 |
Product
CRE Wireguided 8-10mm 240cm
Reason for recall
Potential sterile breach of the pouches in which devices are packaged.
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-2633-2026. 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.