FDA Device recall Z-1250-2026
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
- FDA Device
- Class II
- ongoing
- Published 2026-02-11
On 2026-02-11 the FDA classified a Class II recall of Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25 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-1250-2026 |
| 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 25GA I.D.D. Internal Delivery Device, VS0250.25
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 810123480456 Box UDI 810123480739 Lot 2410044 |
|---|
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-1250-2026%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.