NES Reprocessed Visions PV — Class II medical device recall Z-2334-2021
Terminated recall by Northeast Scientific Inc., reported 2021-09-01, distributed nationwide. 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
| Recall number | Z-2334-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Northeast Scientific Inc., Waterbury, CT, United States |
| Recall initiated | 2021-04-26 |
| Classified | 2021-08-23 |
| Reported by FDA | 2021-09-01 |
| Terminated | 2022-03-09 |
| Distributed | Nationwide (US) |
| Quantity | 690 devices |
| Reason classes | unapproved product |
| Lot numbers | L0017886 |
| Model numbers | R-88901 |
Product
NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901
Reason for recall
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
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-2334-2021. 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.