Reckitt Benckiser LLC: Medical Device Recall in 2018 - (Recall #: Z-3241-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

Product Classification:

Class II

Date Initiated: July 23, 2018

Date Posted: October 3, 2018

Recall Number: Z-3241-2018

Event ID: 80841

Reason for Recall:

The products failed the filed specification of 1.0kPa for Burst Pressure.

Status: Terminated

Product Quantity: 487980 condoms

Code Information:

Batch Numbers: 1000427177, 1000408620, 1000430764

Distribution Pattern:

US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated