Vortex Disposable Forceps and Cannula 1 — Class II medical device recall Z-1247-2026
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-1247-2026 |
|---|---|
| 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 | 00810123480302, 00810123480319, 00810123480326, 00810123480388, 00810123480395, 00810123480562, 00810123480586, 00810123480593, 00810123480609, 00810123480661, 00810123480678, 00810123481101, 00810123481125, 00810123481132, 00810123481231, 00810123481248, 00810123481255, 00810123481514, 00810123481538, 00810123481545, 00810123481644, 00810123481651, 00810123481668, 00810123481835, 00810123481859 and 3 more |
| Lot numbers | 23GA, 2410021, 2410037, 2410039, 2410040, 2410041, 2410042, 2410050, 2410051, 2410053, 2410054, 2410059, 2410060, 2411003, 2411006, 2411009, 2411011, 2411018, 2411032, 2412026, 25GA, 27GA, ACTU8 |
Product
Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Cannula-Bulk VS0200.25B 15. 27GA Soft Tip Cannula VS0200.27
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-1247-2026. 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.