CooperSurgical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1814-2015)

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 OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80

Product Classification:

Class II

Date Initiated: May 20, 2015

Date Posted: June 24, 2015

Recall Number: Z-1814-2015

Event ID: 71329

Reason for Recall:

A diaphragm size 80 labeled box was incorrectly packaged with a size 85.

Status: Terminated

Product Quantity: 200 units

Code Information:

Lot 153309

Distribution Pattern:

AK, CA, DC, FL, IL, ME, MT, NE, NJ, NM, NY, OK, OR, P A, VA, W A, and WI Foreign: CANADA, ENGLAND, and POLAND

Voluntary or Mandated:

Voluntary: Firm initiated