ViziShot 2 Single Use Aspiration Needle — Class III medical device recall Z-1615-2023
Ongoing recall by Olympus Corporation of the Americas, reported 2023-05-31. Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and r
| Recall number | Z-1615-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2023-03-31 |
| Classified | 2023-05-19 |
| Reported by FDA | 2023-05-31 |
| Countries outside the US | CA, DE |
| Quantity | 2,058 |
| UPC / GTIN / UDI-DI | 04953170388248 |
| Lot numbers | KR243729, KR248648, KR248652, KR248673, KR248784, KR248785, KR248808, KR249160, KR251593, KR257313, KR257314, KR264662, KR264697, KR264708, KR264711, KR264726, KR264732, KR264746, KR264751, KR264778, KR264806, KR276770 |
| Model numbers | NA-U401SX-4021, NA-U401SX-4021-A |
Product
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
Reason for recall
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
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-1615-2023. 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.