NES Reprocessed 1 — Class II medical device recall Z-0024-2026
Ongoing recall by Northeast Scientific Inc., reported 2025-10-08, distributed nationwide. Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
| Recall number | Z-0024-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Northeast Scientific Inc., Waterbury, CT, United States |
| Recall initiated | 2025-08-29 |
| Classified | 2025-10-02 |
| Reported by FDA | 2025-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 616 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00850044399109 |
| Model numbers | R-417-156 |
Product
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.
Reason for recall
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
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-0024-2026. 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.