Ansell Healthcare Products LLC: Medical Device Recall in 2013 - (Recall #: Z-0838-2013)

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:

LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).

Product Classification:

Class II

Date Initiated: January 14, 2013

Date Posted: February 27, 2013

Recall Number: Z-0838-2013

Event ID: 64246

Reason for Recall:

Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking to have all products returned.

Status: Terminated

Product Quantity: 469,134 units

Code Information:

Zero Regular 10-Ct: SKU# 0-70907-20510-5 Master Case: 30070907205106.

Distribution Pattern:

.Nationwide Distribution including the states of AL, AZ, CA, CO, DE, FL, GA, IA, IN, IL, KS, KY, LA, MI, MN, MO.MS, NC, NH, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WI and UT.

Voluntary or Mandated:

Voluntary: Firm initiated