Convenience Kits 1 — Class II medical device recall Z-1249-2026
Ongoing recall by Vortex Surgical Inc., reported 2026-02-11, distributed nationwide. There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A
| Recall number | Z-1249-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vortex Surgical Inc., Saint Charles, MO, United States |
| Recall initiated | 2025-12-16 |
| Classified | 2026-02-04 |
| Reported by FDA | 2026-02-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CH, CL, CN, DE, ES, FR, GB, IE, IN, IT, JP, KR, MX, NL, PH, PL, TW, VN |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00810123482412, 00810123482429, 00810123482436, 00810123482443, 00810123482917, 00810123482924 |
| Lot numbers | 2410055, 2410057, 2411028, 25GA |
Product
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1249-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.