FDA Device recall Z-3241-2018
Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthet…
- FDA Device
- Class II
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class II recall of Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthet… by Reckitt Benckiser, citing the products failed the filed specification of 1.0kPa for Burst Pressure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3241-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-23 |
| Published | 2018-10-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Reckitt Benckiser |
| Distribution | US |
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
The products failed the filed specification of 1.0kPa for Burst Pressure.
Identifiers
| code_info | Batch Numbers: 1000427177, 1000408620, 1000430764 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3241-2018%22
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