Class II — MICROVENTION INC.
| Recalling firm | MicroVention Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed. |
| Product | TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 |
| Quantity | 22 units |
| Distribution | U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI. |
| Initiated | 2023-12-21 |
| Classified | 2024-01-31 |
| Recall number | Z-0868-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — MICROVENTION INC. (Z-0868-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93692/
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