Durex Synthetic Polyisoprene Condoms Recalled for Burst Pressure Concerns
Reckitt Benckiser LLC is recalling Durex Synthetic polyisoprene condoms in New York due to insufficient data ensuring they meet internal burst pressure specifications at the end of their 5-year shelf life.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (contraceptive failure) where injury or illness has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Reckitt Benckiser LLC is recalling Durex Synthetic polyisoprene male condoms. The product is used for contraception and to help prevent the transmission of sexually transmitted diseases. The recall involves 34 cartons containing 12 condoms each, for a total of 408 condoms. The specific lot number is 1000490884.
The recall was initiated because the product does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of its 5-year shelf life. The affected units were distributed in the state of New York.
Consumers who have purchased these specific condoms should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
- Manufacturer
- Reckitt Benckiser LLC
- Category
- Medical Device — Contraceptives
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)
- Lot Number - 1000490884
Distribution
Distributed in 1 state:
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