Durex Real Feel Polyisoprene Condoms — Class II medical device recall Z-3241-2018
Terminated recall by Reckitt Benckiser LLC, reported 2018-10-03, distributed nationwide. The products failed the filed specification of 1.0kPa for Burst Pressure.
| Recall number | Z-3241-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Reckitt Benckiser LLC, Parsippany, NJ, United States |
| Recall initiated | 2018-07-23 |
| Classified | 2018-09-24 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2020-03-05 |
| Distributed | Nationwide (US) |
| Quantity | 487,980 condoms |
| Lot numbers | 1000408620, 1000427177, 1000430764 |
Product
Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 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
The products failed the filed specification of 1.0kPa for Burst Pressure.
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-3241-2018. 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.