Oertli 1 — Class II medical device recall Z-1246-2026
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-1246-2026 |
|---|---|
| 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 | 00810123483716, 00810123483723, 00810123483730, 00810123483747, 00810123483761, 00810123483778, 00810123483785, 00810123483792, 00810123483808, 00810123483815, 00810123483822, 00810123483846, 00810123483853, 00810123483860 |
| Lot numbers | 2410031, 2410032, 2410033, 2410034, 2410035, 2410058, 2411021, 2411022, 2412025 |
Product
Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327
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-1246-2026. 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.