CooperSurgical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0105-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: September 1, 2015

Date Posted: October 14, 2015

Recall Number: Z-0105-2016

Event ID: 72107

Reason for Recall:

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

Status: Terminated

Product Quantity: 305 units

Code Information:

LOT 187889

Distribution Pattern:

US Distribution to the states of : AL, AZ, CA, GA, IA, IL, KS, LA, MA, MD, MN, MO, MS, NY, OH, PA, TN, TX, VA, and VT.

Voluntary or Mandated:

Voluntary: Firm initiated