Northeast Scientific Inc.: Medical Device Recall in 2025 - (Recall #: Z-0018-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 29, 2025

Date Posted: October 8, 2025

Recall Number: Z-0018-2026

Event ID: 97524

Reason for Recall:

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Status: Ongoing

Product Quantity: 561 units

Code Information:

Model No R-410-152; UDI-DI 00850044399055; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026

Distribution Pattern:

US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.

Voluntary or Mandated:

Voluntary: Firm initiated