TERUMO HydroPearl Compressible Microspheres for Embolisation REF… — Class II medical device recall Z-0868-2024
Ongoing recall by MICROVENTION INC., reported 2024-02-07, distributed nationwide. Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed
| Recall number | Z-0868-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MICROVENTION INC., Aliso Viejo, CA, United States |
| Recall initiated | 2023-12-21 |
| Classified | 2024-01-31 |
| Reported by FDA | 2024-02-07 |
| Distributed | Nationwide (US) |
| Quantity | 22 units |
| UPC / GTIN / UDI-DI | 00816777026118 |
| Lot numbers | 0000342047 |
| Model numbers | 8HP2S600, HP2S0600 |
Product
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Reason for recall
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
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-0868-2024. 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.