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Northeast Scientific Inc. recalls NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-E
Recalled October 8, 2025 · FDA recall Z-0023-2026 · Northeast Scientific
Hazard
Potential for breaches in the sterile barrier packaging, compromising sterility assurance. · FDA Class II
Units
1,019 units
Sold at
US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
Description
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Product
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. 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.
Manufacturer(s)
Northeast Scientific Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →