ViziShot 2FLEX — Class I medical device recall Z-2484-2025
Ongoing recall by Olympus Corporation of the Americas, reported 2025-09-17, distributed nationwide. Potential for undetected, deformed a-traumatic tips.
| Recall number | Z-2484-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2025-08-06 |
| Classified | 2025-09-05 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CL, CN, DE, HK, IN, JP, SG |
| Quantity | 104,508 units |
| UPC / GTIN / UDI-DI | 00821925043060 |
| Model numbers | NA-U403SX-4019 |
Product
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the needle tube.
Reason for recall
Potential for undetected, deformed a-traumatic tips.
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-2484-2025. 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.