FDAHealthAugust 29, 2025
Northeast Scientific Inc. — NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use
⚠️ Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 29, 2025
US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
What's affected?
- Product
- NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. 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.
- Lot code
- that
Additional details
Model No R-420-159; UDI-DI 00850044399086; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 141 units.
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