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.
Other recalls by Ansell Healthcare Products
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FDA Device · Class II · 2023-10-18 · Ansell Healthcare Products - GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
FDA Device · Class II · 2023-10-18 · Ansell Healthcare Products - Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
FDA Device · Class II · 2022-04-06 · Ansell Healthcare Products - MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical…
FDA Device · Class II · 2020-10-14 · Ansell Healthcare Products - Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd
FDA Device · Class II · 2016-12-28 · Ansell Healthcare Products
All Ansell Healthcare Products recalls
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.