Ansell Recalls LifeStyles ZERO 10 Latex Condoms Due to Breakage Complaints
Ansell Healthcare Products LLC is voluntarily recalling LifeStyles ZERO 10 latex condoms due to complaints about difficulty unrolling and breakage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall initiated out of an abundance of caution due to functional complaints (breakage) rather than confirmed injuries or FDA Class I classification.
Plain-English summary
Ansell Healthcare Products LLC is voluntarily recalling LifeStyles ZERO 10 uber-thin lubricated latex condoms. The recall involves 469,134 units distributed nationwide, including in states such as Alabama, Arizona, California, and Texas. The product is identified by SKU# 0-70907-20510-5 and Master Case 30070907205106.
The company initiated the recall out of an abundance of caution following complaints regarding the difficulty in unrolling the condoms and subsequent breakage. The source text notes that the condoms have met or exceeded test and quality standards required by the Food and Drug Administration, but the firm is requesting the return of all products to address these issues.
Consumers who have purchased these condoms should stop using them and return them to the point of purchase or contact the recalling firm for instructions.
The recalled product
- 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…
- Manufacturer
- Ansell Healthcare Products LLC
- Category
- Medical Device — Contraceptives
- Hazard
- Affected units
- 469,134
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Zero Regular 10-Ct: SKU# 0-70907-20510-5 Master Case: 30070907205106.
Distribution
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