FDAFDA · Food and drugs·Recall number Z-0024-2026
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.
Published October 8, 2025 · Recall initiated: August 29, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Northeast Scientific Inc.
- Distributor
- US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
- Lot
- Model No R-417-156; UDI-DI 00850044399109; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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