Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Recalled by Northeast Scientific Inc. Due to Potential for breaches in the sterile barrier packaging,...

Date: August 29, 2025
Company: Northeast Scientific Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Northeast Scientific Inc. directly.

Affected Products

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.

Quantity: 173 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Northeast Scientific Inc.

Northeast Scientific Inc. has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report