Cooper Surgical, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1018-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.

Product Classification:

Class II

Date Initiated: February 26, 2013

Date Posted: April 3, 2013

Recall Number: Z-1018-2013

Event ID: 64510

Reason for Recall:

Incorrect size was printed on the outer product packaging.

Status: Terminated

Product Quantity: 80 individual diaphragms

Code Information:

Lot 113367

Distribution Pattern:

Worldwide Distribution -- USA, including the states of NE, MA, FL, TN, CA, ME, SC, CA, NH, OK, TX, NM, MO, NY, PA, and AZ, and countries of Germany, Italy, and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated