Northeast Scientific Inc. recalls NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-El…

Recall date

August 29, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0021-2026

FDA classification

Class II

Brand / firm

Northeast Scientific Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. 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.