FDA Device recall Z-1256-2026
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
- FDA Device
- Class II
- ongoing
- Published 2026-02-11
On 2026-02-11 the FDA classified a Class II recall of Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker 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-1256-2026 |
| 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
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
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 810123483655 Box UDI 810123483662 Lot 2408035 |
|---|
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-1256-2026%22
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