Northeast Scientific Inc.: Medical Device Recall in 2025 - (Recall #: Z-0019-2026)
See the recall detail below. You can also see other recalls from the same firm in 2025.
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. 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.
Class II
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Model No R-414-151; UDI-DI 00850044399116; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026
US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
Voluntary: Firm initiated
