Z-0838-2013Class II

LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL...

Name: Z-0838-2013 LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL...
Creator: Ansell Healthcare Products LLC
Published: 2013-01-14
License: https://open.fda.gov/license/

Ansell Healthcare Products LLC / initiated 2013-01-14 / Terminated / root cause: design

FDA source

Ansell Healthcare Products LLC began a recall of LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis... on 2013-01-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0838-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-14
Posted: 2013-02-20
Terminated: 2015-08-06
Recalling firm: Ansell Healthcare Products LLC
Product: 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 code: HIS Condom
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.
Root cause tag: design
FDA root cause: Device Design
Action: Ansell HealthCare Product LLC sent an Recall letter dated January 14, 2013, via registered mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recall notification informs customers about the problem with the affected product and provides instructions to the customers on how to handle affected product. Customers are asked to complete the Response Form and return via fax (1-800) 722-8155. If you have further questions, please contact our Customer Service Department at 1-800-952-9916.
Quantity in commerce: 469,134 units
Distribution: .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.
Product codes and lots: Zero Regular 10-Ct: SKU# 0-70907-20510-5 Master Case: 30070907205106.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0838-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0838-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20

Product code HIS

K120394Class IILifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC / cleared 2012-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)