RecallWatchUSA

Home / Recalls / Medical Devices

Northeast Scientific Inc. recalls NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-

Recalled October 8, 2025 · FDA recall Z-0018-2026 · Northeast Scientific

Hazard
Potential for breaches in the sterile barrier packaging, compromising sterility assurance. · FDA Class II
Units
561 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 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
Manufacturer(s)
Northeast Scientific Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov