Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene… — Class II medical device recall Z-0091-2019
Terminated recall by Reckitt Benckiser LLC, reported 2018-10-17, distributed in NY. Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure
| Recall number | Z-0091-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Reckitt Benckiser LLC, Parsippany, NJ, United States |
| Recall initiated | 2018-08-06 |
| Classified | 2018-10-09 |
| Reported by FDA | 2018-10-17 |
| Terminated | 2019-11-12 |
| Distributed | NY |
| Lot numbers | 1000490884 |
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).
Reason for recall
Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0091-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.