Northeast Scientific Inc.: Device Recall
Recall #Z-0020-2026 · 08/29/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0020-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Northeast Scientific Inc.
- Status
- Ongoing
- Date Initiated
- 08/29/2025
- Location
- Waterbury, CT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 165 units
Reason for Recall
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Product Description
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. 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.
Distribution Pattern
US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
Other Recalls by Northeast Scientific Inc.
- Class II: Risk 08/29/2025
- Class II: Risk 08/29/2025
- Class II: Risk 08/29/2025
- Class II: Risk 08/29/2025
- Class II: Risk 08/29/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.