CLASS II Device recall · Reported 3 Oct 2018 · FDA Enforcement Report
Durex Real Feel Polyisoprene Condoms recalled by Reckitt Benckiser
Reckitt Benckiser is recalling Durex Real Feel Polyisoprene Condoms, distributed nationwide in the US. The recall was initiated on 23 Jul 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3241-2018
- FDA event ID
- 80841
- Recalling firm
- Reckitt Benckiser, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jul 2018
- FDA classified
- 24 Sep 2018
- Reported
- 3 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 23 Jul 2018 | Recall initiated by company | |
| 24 Sep 2018 | Classified by FDA | +63 days |
| 3 Oct 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The products failed the filed specification of 1.0kPa for Burst Pressure.
Product as listed by the FDA
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).
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
The products failed the filed specification of 1.0kPa for Burst Pressure.
Which lots are affected?
Batch Numbers: 1000427177, 1000408620, 1000430764
Where was it sold?
US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Reckitt Benckiser
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Durex Real Feel, synthetic polisoprene male condom recalled | Reckitt Benckiser | Other | Nationwide |
| Device | CLASS II | Durex Pleasure Pack, synthetic polisoprene male condom recalled | Reckitt Benckiser | Other | Nationwide |
| Device | CLASS II | Polyisoprene condomns recalled by Reckitt Benckiser | Reckitt Benckiser | Device Malfunction | NY |
| Device | CLASS II | Durex Pleasure Pack . 3 ultra fine lubricated latex condoms recalled | Reckitt Benckiser | Labeling Errors | Nationwide |
| Drug | CLASS III | Mucinex Sinus-Max Day Night, 60 caplets recalled by Reckitt Benckiser | Reckitt Benckiser | Other | FL, MA, NJ |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |