The Recall Desk

FDA (Devices) recall action 81964

Reckitt Benckiser LLC recalled 2 products on 2019-03-20

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-03-20
Critical
0
Units
1,795,964

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2019-03-20

    Durex Real Feel Condoms Recalled for Burst Pressure Failure

    Reckitt Benckiser LLC is recalling Durex Real Feel condoms because five batches failed burst pressure specifications.

    Product
    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-03-20

    Durex Pleasure Pack Condoms Recalled for Burst Pressure Failure

    Reckitt Benckiser is recalling Durex Pleasure Pack condoms because five batches failed burst pressure specifications.

    Product
    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
    Category
    Distribution
    0 states