CLASS II Device recall · Reported 17 Oct 2018 · FDA Enforcement Report
Polyisoprene condomns recalled by Reckitt Benckiser
Reckitt Benckiser is recalling Polyisoprene condomns, distributed in New York. The recall was initiated on 6 Aug 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-0091-2019
- FDA event ID
- 80939
- Recalling firm
- Reckitt Benckiser, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2018
- FDA classified
- 9 Oct 2018
- Reported
- 17 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 6 Aug 2018 | Recall initiated by company | |
| 9 Oct 2018 | Classified by FDA | +64 days |
| 17 Oct 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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).
Where it was distributed
US in the states of NY
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot Number - 1000490884
Where was it sold?
US in the states of NY
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 | Durex Real Feel Polyisoprene Condoms recalled by Reckitt Benckiser | Reckitt Benckiser | Other | Nationwide |
| 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 |
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| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |