FDA Device recall Z-0850-2020
VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386
- FDA Device
- Class II
- terminated
- Published 2020-02-05
On 2020-02-05 the FDA classified a Class II recall of VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386 by Vitreq Bv, citing microscopic tears of the sterile pouch may compromise sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0850-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-17 |
| Published | 2020-02-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Vitreq Bv |
| Distribution | US |
Product
VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386
Reason
Microscopic tears of the sterile pouch may compromise sterility
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0850-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.