CooperSurgical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2098-2015)

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:

Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that result in constriction of the vaginal and/or rectal orifice

Product Classification:

Class II

Date Initiated: June 19, 2015

Date Posted: July 29, 2015

Recall Number: Z-2098-2015

Event ID: 71582

Reason for Recall:

Incorrect expiration date on outer carton kit label

Status: Terminated

Product Quantity: 40 kits

Code Information:

LOT 156966

Distribution Pattern:

US Nationwide Distribution in the states of: CA, FL, GA, HI, IL, KY, MD, MN, NC, NY, OH, TX, VT, and W A.

Voluntary or Mandated:

Voluntary: Firm initiated