FDA (Devices) recall action 81964
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.
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.
Reckitt Benckiser is recalling Durex Pleasure Pack condoms because five batches failed burst pressure specifications.
Reckitt Benckiser LLC is recalling Durex Real Feel condoms because five batches failed burst pressure specifications.