Z-0994-2019Class II

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

Name: Z-0994-2019 Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00...
Creator: Reckitt Benckiser LLC
Published: 2018-12-19
License: https://open.fda.gov/license/

Reckitt Benckiser LLC / initiated 2018-12-19 / Terminated

FDA source

Reckitt Benckiser LLC began a recall of 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 on 2018-12-19. FDA classified it as Class II and gives the reason as "Five batches of the product have failed the specification of 1.0kPa for Burst Pressure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0994-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-19
Posted: 2019-03-09
Terminated: 2021-03-26
Recalling firm: Reckitt Benckiser LLC
Product: 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
Product code: MOL Condom, Synthetic
Reason for recall: Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
FDA root cause: Under Investigation by firm
Action: On December 19, 2018, the firm issued Urgent Medical Device Recall letters to wholesale customers. The letter advised customers of the product issue, and reminded customers that the product labeling states, "Should a condom break or leak during use, seek medical assistance as soon as possible, at least within 72 hrs." Customers are asked to do the following: 1. Examine inventory in your distribution center immediately to determine if you have the specified batch in your warehouse inventory. 2. Segregate and return the specified batch. 3. A pre-paid return label is provided by the firm for your convenience to return the product. Contact Stericycle Expert Solutions at 888-843-0252 for assistance if you need additional labels or help with coordination of pickup and removal of product from your facility. Contact Information: Phone: 888-843-0252 Fax: 855-880-6687 Email: [email protected] 4. Alternatively, you may arrange shipment of product directly to Stericycle at the following address: Attn: Event 3552 2670 Executive Drive, Suite A Indianapolis, IN 46241 Dock Hours are 8AM - 4:30PM Monday - Friday Please call to schedule a dock appointment 5. Finally, notify Stericycle representative by completing and returning the Business Response Form via email [email protected] that you have: a. Checked your inventory in your distribution centers and confirm you have NO product of the specified batch. b. You have collected all units in your inventory and product has been shipped back in accordance with the instructions from your Stericycle representative. Please direct any questions or concerns with this recall to Stericycle Representative at 877-448-5308 and reference event 3552. For general inquiry not related to the recall, please contact RB Custo er Service Director, Robert Drennan at 201-220-8531.
Quantity in commerce: 34920
Distribution: Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.
Product codes and lots: WO00905865 WO00905864 WO00901945 WO00900899 WO00900900 WO00900901

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0994-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0993-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-08
Z-0994-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-08

Product code MOL

K072169Class IIDurex Synthetic Polyisoprene Male CondomSsl Americas, Inc. / cleared 2008-06-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)