FDA Device recall Z-0868-2024
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
- FDA Device
- Class II
- ongoing
- Published 2024-02-07
On 2024-02-07 the FDA classified a Class II recall of TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 by Microvention, citing due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0868-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-21 |
| Published | 2024-02-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Microvention |
| Distribution | US |
Product
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Reason
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
Identifiers
| code_info | Model/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0868-2024%22
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