FDA Device recall Z-0993-2019
Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-95…
- FDA Device
- Class II
- terminated
- Published 2019-03-20
On 2019-03-20 the FDA classified a Class II recall of Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-95… by Reckitt Benckiser, citing five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0993-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-19 |
| Published | 2019-03-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Reckitt Benckiser |
| Distribution | US |
Product
Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-95767-00 02340-89456-14 02340-89457-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-89455-00 02340-95767-00 02340-95767-00
Reason
Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
Identifiers
| code_info | 1000314778 1000289702 1000322841 1000329839 1000317735 1000323210 1000318792 1000170515 1000240186 1000378288…1000314778 1000289702 1000322841 1000329839 1000317735 1000323210 1000318792 1000170515 1000240186 1000378288 1000183941 1000350794 1000270527 1000277098 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0993-2019%22
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