CLASS II Device recall · Reported 20 Mar 2019 · FDA Enforcement Report

Durex Real Feel, synthetic polisoprene male condom recalled

Reckitt Benckiser is recalling Durex Real Feel, synthetic polisoprene male condom, distributed nationwide in the US. The recall was initiated on 19 Dec 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1000314778 1000289702 1000322841 1000329839 1000317735 1000323210 1000318792 1000170515 1000240186 1000378288 1000183941 1000350794 1000270527 1000277098

Quantity recalled1761044

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-0993-2019
FDA event ID: 81964
Recalling firm: Reckitt Benckiser, Parsippany, NJ
Classification: Class II
Status: Terminated
Recall initiated: 19 Dec 2018
FDA classified: 8 Mar 2019
Reported: 20 Mar 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

19 Dec 2018	Recall initiated by company
8 Mar 2019	Classified by FDA	+79 days
20 Mar 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.

Product as listed by the FDA

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

Where it was distributed

Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.

Nationwide

Questions about this recall

Why was it recalled?

Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.

Which lots are affected?

1000314778 1000289702 1000322841 1000329839 1000317735 1000323210 1000318792 1000170515 1000240186 1000378288 1000183941 1000350794 1000270527 1000277098

Where was it sold?

Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.

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.

Other products in this recall event

1 other product · FDA event 81964

This product is part of a recall event; the main page for the event is Durex Pleasure Pack, synthetic polisoprene male condom recalled.

Reported	Class	Recall	Company	Reason	Where
20 Mar 2019	CLASS II	Durex Pleasure Pack, synthetic polisoprene male condom recalled	Reckitt Benckiser	Other	Nationwide

More recalls from Reckitt Benckiser

All 15

Reported	Class	Recall	Company	Reason	Where
20 Mar 2019Device	CLASS II	Durex Pleasure Pack, synthetic polisoprene male condom recalled	Reckitt Benckiser	Other	Nationwide
17 Oct 2018Device	CLASS II	Polyisoprene condomns recalled by Reckitt Benckiser	Reckitt Benckiser	Device Malfunction	NY
3 Oct 2018Device	CLASS II	Durex Real Feel Polyisoprene Condoms recalled by Reckitt Benckiser	Reckitt Benckiser	Other	Nationwide
1 Mar 2017Device	CLASS II	Durex Pleasure Pack . 3 ultra fine lubricated latex condoms recalled	Reckitt Benckiser	Labeling Errors	Nationwide
28 Sep 2016Drug	CLASS III	Mucinex Sinus-Max Day Night, 60 caplets recalled by Reckitt Benckiser	Reckitt Benckiser	Other	FL, MA, NJ

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