Class II — Vitreq Bv
| Recalling firm | VITREQ BV |
|---|---|
| Registered facility | VITREQ BV (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Microscopic tears of the sterile pouch may compromise sterility |
| Product | VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386 |
| Quantity | N/A |
| Distribution | Nationwide |
| Initiated | 2019-12-17 |
| Classified | 2020-01-24 |
| Terminated | 2020-12-09 |
| Recall number | Z-0850-2020 |
| 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 — Vitreq Bv (Z-0850-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84661/
Alerts for VITREQ BV
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.