Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Recalled by CooperSurgical, Inc. Due to Kit Label incorrect :Labeled with Lidocaine HCI drug...

Date: September 1, 2015
Company: CooperSurgical, 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 CooperSurgical, Inc. directly.

Affected Products

CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061

Quantity: 305 units

Why Was This Recalled?

Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)

Where Was This Sold?

This product was distributed to 20 states: AL, AZ, CA, GA, IL, IA, KS, LA, MD, MA, MN, MS, MO, NY, OH, PA, TN, TX, VT, VA

Affected (20 states)Not affected

About CooperSurgical, Inc.

CooperSurgical, Inc. has 83 total recalls tracked by RecallDetector.

Related Recalls

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