Durex Real Feel Polyisoprene Condoms Recalled for Burst Pressure Failure
Reckitt Benckiser is recalling Durex Real Feel Polyisoprene Condoms because they failed to meet the required burst pressure specification.
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 is classified as FDA Class II, and the failure of a contraceptive device to meet burst pressure specifications poses a risk of harm (unintended pregnancy or STI transmission) even though specific injuries are not reported in the source text.
Plain-English summary
Reckitt Benckiser LLC is recalling Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, due to a failure to meet the filed specification for Burst Pressure. The affected products are identified by SKU Numbers 02340-89456-14 and 02340-89457-00 and Batch Numbers 1000427177, 1000408620, and 1000430764.
The recall involves 487,980 units distributed nationwide in the United States. These condoms are used for contraception and to help prevent the transmission of sexually transmitted diseases.
Consumers should stop using the affected products and contact Reckitt Benckiser for further instructions or a refund.
The recalled product
- Product
- Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of…
- Manufacturer
- Reckitt Benckiser LLC
- Affected units
- 487,980
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 (3)
- Batch Numbers: 1000427177
- 1000408620
- 1000430764
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Reckitt Benckiser LLC
See all →- HighDurex Real Feel Condoms Recalled for Burst Pressure Failure
FDA (Devices) · 2019-03-20
- HighDurex Pleasure Pack Condoms Recalled for Burst Pressure Failure
FDA (Devices) · 2019-03-20
- HighDurex Synthetic Polyisoprene Condoms Recalled for Burst Pressure Concerns
FDA (Devices) · 2018-10-17
- ModerateDurex Condoms Recalled for Missing Benzocaine Labeling Information
FDA (Devices) · 2017-03-01
- ModerateMucinex Sinus-Max Day Night Recalled for Labeling Errors
FDA (Drugs) · 2016-09-28
Similar recalls
- HighDurex Real Feel Condoms Recalled for Burst Pressure Failure
FDA (Devices) · 2019-03-20
- HighDurex Synthetic Polyisoprene Condoms Recalled for Burst Pressure Concerns
FDA (Devices) · 2018-10-17
- HighDurex Pleasure Pack Condoms Recalled for Burst Pressure Failure
FDA (Devices) · 2019-03-20
- ModerateDurex Condoms Recalled for Missing Benzocaine Labeling Information
FDA (Devices) · 2017-03-01
- ModerateTeleflex Medical Recalls Rectal Catheters Due to Missing Latex Warning
FDA (Devices) · 2018-04-18
- ModerateAnsell Recalls LifeStyles ZERO 10 Latex Condoms Due to Breakage Complaints
FDA (Devices) · 2013-02-27