LifeStyles ZERO 10 uber-thin lubricated latex condoms — Class II medical device recall Z-0838-2013

Terminated recall by Ansell Healthcare Products LLC, reported 2013-02-27, distributed nationwide. Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) p

Recall number	`Z-0838-2013`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Ansell Healthcare Products LLC, Iselin, NJ, United States
Recall initiated	2013-01-14
Classified	2013-02-20
Reported by FDA	2013-02-27
Terminated	2015-08-06
Distributed	Nationwide (US)
Quantity	469,134 units
Reason classes	device malfunction
UPC / GTIN / UDI-DI	`00070907205105`, `30070907205106`

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).

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0838-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.