Class II — Potential Health Hazard

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

NvisionVLE¿ Low-Profile Optical Probe Recalled by Ninepoint Medical Inc. Due to Distal tips of the probes may detach from...

Date: April 11, 2018
Company: Ninepoint Medical Inc.
Status: Terminated
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 Ninepoint Medical Inc. directly.

Affected Products

NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188(17)180930(10)005275) Product Usage: The NvisionVLE Low-Profile Optical Probe is intended to be used for imaging the micro-structure of human tissue. When used with the NvisionVLE Imaging System it provides two-dimensional, cross-sectional, real-time depth visualization.

Quantity: 152

Why Was This Recalled?

Distal tips of the probes may detach from the probe shaft during use.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ninepoint Medical Inc.

Ninepoint Medical Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

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