CooperSurgical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2112-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21

Product Classification:

Class II

Date Initiated: April 9, 2020

Date Posted: June 3, 2020

Recall Number: Z-2112-2020

Event ID: 85544

Reason for Recall:

The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.

Status: Terminated

Product Quantity: 1740 units/174 boxes

Code Information:

Lot # 257589

Distribution Pattern:

Distribution to North America including the following states: AZ, CA, CT, DC, DE, FL, GA, IA, IN, MA, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI

Voluntary or Mandated:

Voluntary: Firm initiated