Reckitt Benckiser LLC: Medical Device Recall in 2018 - (Recall #: Z-0091-2019)

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:

Polyisoprene condomns 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: August 6, 2018

Date Posted: October 17, 2018

Recall Number: Z-0091-2019

Event ID: 80939

Reason for Recall:

Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life

Status: Terminated

Product Quantity: 34 cartons/12 condoms each (408 condoms total)

Code Information:

Lot Number - 1000490884

Distribution Pattern:

US in the states of NY

Voluntary or Mandated:

Voluntary: Firm initiated