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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (condoms) where the failure of burst pressure specifications implies a risk of injury or unintended pregnancy, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Reckitt Benckiser LLC is recalling Durex Real Feel synthetic polyisoprene male condoms. The recall involves 1,761,044 units distributed nationwide in the United States and in Barbados, Jamaica, Aruba, Guyana, Haiti, and St. Maarten.
The recall was initiated because five batches of the product failed the specification of 1.0kPa for Burst Pressure. The affected products are identified by specific SKUs and lot codes listed in the official recall notice.
Consumers who have purchased these specific batches should stop using the product and contact the manufacturer for a refund or replacement.
The recalled product
- 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
- Manufacturer
- Reckitt Benckiser LLC
- Category
- Medical Device — Condoms
- Hazard
- Affected units
- 1,761,044
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Reckitt Benckiser LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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