Class II — Potential Health Hazard

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

Cook Multi-Use Holmium Laser Fibers Recalled by Cook Inc. Due to Correction to the product Instructions for Use because...

Date: May 9, 2017
Company: Cook 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 Cook Inc. directly.

Affected Products

Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages

Quantity: 4369

Why Was This Recalled?

Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.

Where Was This Sold?

This product was distributed to 31 states: AL, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, KY, LA, MD, MI, MS, MO, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI

Affected (31 states)Not affected

About Cook Inc.

Cook Inc. has 262 total recalls tracked by RecallDetector.

Related Recalls

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