Z-1249-2017Class II

Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine...

Name: Z-1249-2017 Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine...
Creator: Reckitt Benckiser LLC
Published: 2016-11-22
License: https://open.fda.gov/license/

Reckitt Benckiser LLC / initiated 2016-11-22 / Terminated / root cause: labeling and UDI

FDA source

Reckitt Benckiser LLC began a recall of Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC... on 2016-11-22. FDA classified it as Class II and gives the reason as "Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1249-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Posted: 2017-02-23
Terminated: 2020-01-15
Recalling firm: Reckitt Benckiser LLC
Product: Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274-08-6 24 ct - UPC 302340-302190-04 (contacting firm for label)
Product code: HIS Condom
Reason for recall: Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Reckitt Benckiser LLC sent an Urgent Medical Device Recall letter/business response form dated November 22, 2016 to the affected customers. Stericylcle is handling returns.
Quantity in commerce: 108342 units
Distribution: Nationwide and Foreign
Product codes and lots: 3ct - item code 02340-30042-04 lot code exp date 3 ct - Walmart item code 02340-70042-04 lot code exp date 12ct - item code 02340-30274-08 lot code exp date 24 ct - item code 02340-302190-04 lot codes and exp date

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1249-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1249-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-23

Product code HIS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)