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

FDA Device Recall #Z-0838-2013 — Class II — January 14, 2013

Recall Summary

Recall Number Z-0838-2013
Classification Class II — Moderate risk
Date Initiated January 14, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ansell Healthcare Products LLC
Location Iselin, NJ
Product Type Devices
Quantity 469,134 units

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).

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.

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.

Lot / Code Information

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

Other Recalls from Ansell Healthcare Products LLC

Recall # Classification Product Date
Z-0097-2024 Class II NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical glo... Aug 3, 2023
Z-0096-2024 Class II GAMMEX NON-LATEX PI GREEN Surgical gloves, REF:... Aug 3, 2023
Z-0838-2022 Class II Gammex Non-Latex PI Green PI-KARE Skin-friendly... Feb 19, 2022
Z-0051-2021 Class II MICROFLEX Diamond Grip Examination Gloves, MF-3... Aug 19, 2020
Z-0893-2017 Class II Gammex Non-Latex Sensitive Neoprene Surgical ... Oct 24, 2016

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.