Reckitt Benckiser LLC: Medical Device Recall in 2019 - (Recall #: Z-0994-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 19, 2018

Date Posted: March 20, 2019

Recall Number: Z-0994-2019

Event ID: 81964

Reason for Recall:

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

Status: Terminated

Product Quantity: 34920

Code Information:

WO00905865 WO00905864 WO00901945 WO00900899 WO00900900 WO00900901

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated