Durex Pleasure Pack Condoms Recalled for Burst Pressure Failure
Reckitt Benckiser is recalling Durex Pleasure Pack 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 injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Reckitt Benckiser LLC is recalling Durex Pleasure Pack (60 ct) synthetic polyisoprene male condoms. The recall involves 34,920 units distributed nationwide and to 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 lot codes are WO00905865, WO00905864, WO00901945, WO00900899, WO00900900, and WO00900901.
Consumers should stop using the recalled condoms and contact the manufacturer for a refund or replacement.
The recalled product
- 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
- Manufacturer
- Reckitt Benckiser LLC
- Category
- Medical Device — Condoms
- Hazard
- Affected units
- 34,920
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- WO00905865 WO00905864 WO00901945 WO00900899 WO00900900 WO00900901
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
Same manufacturer · Reckitt Benckiser LLC
See all →- HighDurex Real Feel Condoms Recalled for Burst Pressure Failure
FDA (Devices) · 2019-03-20
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- HighDurex Real Feel Polyisoprene Condoms Recalled for Burst Pressure Failure
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- ModerateMucinex Sinus-Max Day Night Recalled for Labeling Errors
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