FDA Device recall Z-1248-2026
25GA Subretinal Injection Cannula VS0220.25
- FDA Device
- Class II
- ongoing
- Published 2026-02-11
On 2026-02-11 the FDA classified a Class II recall of 25GA Subretinal Injection Cannula VS0220.25 by Vortex Surgical, citing there may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1248-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-16 |
| Published | 2026-02-11 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Vortex Surgical |
| Distribution | US |
Product
25GA Subretinal Injection Cannula VS0220.25
Reason
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Identifiers
| code_info | Pouch UDI 810123480418 Box UDI 810123480692 Lot 2410043 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1248-2026%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.