Reckitt Benckiser LLC: Medical Device Recall in 2019 - (Recall #: Z-0993-2019)

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 Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-95767-00 02340-89456-14 02340-89457-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-89455-00 02340-95767-00 02340-95767-00

Product Classification:

Class II

Date Initiated: December 19, 2018

Date Posted: March 20, 2019

Recall Number: Z-0993-2019

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: 1761044

Code Information:

1000314778 1000289702 1000322841 1000329839 1000317735 1000323210 1000318792 1000170515 1000240186 1000378288 1000183941 1000350794 1000270527 1000277098

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated