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

Durex Pleasure Pack, synthetic polisoprene male condom recalled

Reckitt Benckiser is recalling Durex Pleasure Pack, 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 codesWO00905865 WO00905864 WO00901945 WO00900899 WO00900900 WO00900901

Quantity recalled34920

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-0994-2019
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 Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00

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?

WO00905865 WO00905864 WO00901945 WO00900899 WO00900900 WO00900901

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

Reported	Class	Recall	Company	Reason	Where
20 Mar 2019	CLASS II	Durex Real Feel, 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 Real Feel, 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

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide