FDA Device recall Z-0838-2013
LifeStyles ZERO 10 uber-thin lubricated latex condoms
- FDA Device
- Class II
- terminated
- Published 2013-02-27
On 2013-02-27 the FDA classified a Class II recall of LifeStyles ZERO 10 uber-thin lubricated latex condoms by Ansell Healthcare Products, citing 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 req….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0838-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-14 |
| Published | 2013-02-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ansell Healthcare Products |
| Distribution | US |
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
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.
Identifiers
| code_info | Zero Regular 10-Ct: SKU# 0-70907-20510-5 Master Case: 30070907205106. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0838-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.