Reckitt Benckiser LLC
United Statesfrom the FDA registration address FDA establishment FEI 3011015568
- Devices
- 71
- Registrations
- FDA
- FDA recalls
- 5
What Reckitt Benckiser LLC makes
The company manufactures personal lubricants, including water-based and silicone-based formulations such as Durex RealFeel Pleasure Gel, K-Y Marilyn Pleasure Gel, and Durex Embrace Lubricant. It also produces topical warming creams like K-Y Touch All-in-one Warming Caressing Creme with integrated lubrication. Additionally, the portfolio includes disinfectant solutions like Sporox and Sporox II for sterilizing and cleaning surfaces, as well as Lysol I.C. Phenolic Disinfectant Cleaner.
These products are classified under FDA device categories, primarily as Class I and Class II medical devices, with regulatory submissions supported via 510(k) clearances. The company’s products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Search and filter all 71 devicesShowing 1-50 of 71
Company details
- FDA FEI number
- 3011015568
- Address
- 100 Metro Blvd, Nutley, NJ, 07110
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 4
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 19 Dec 2018 Z-0993-2019 Class II Terminated Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
- 19 Dec 2018 Z-0994-2019 Class II Terminated Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
- 6 Aug 2018 Z-0091-2019 Class II Terminated Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life
- 23 Jul 2018 Z-3241-2018 Class II Terminated The products failed the filed specification of 1.0kPa for Burst Pressure.
2016
- 22 Nov 2016 Z-1249-2017 Class II Terminated Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine.
Frequently asked questions
How many devices does Reckitt Benckiser LLC have in the registry?
The registry currently lists 71 devices for Reckitt Benckiser LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Reckitt Benckiser LLC's devices?
Among its 50 most recently registered devices, Reckitt Benckiser LLC has devices listed in FDA GUDID (50 devices).
What risk classes do Reckitt Benckiser LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Reckitt Benckiser LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Reckitt Benckiser LLC?
FDA recall records list 5 recalls initiated by Reckitt Benckiser LLC, the most recent initiated on 19 Dec 2018. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Reckitt Benckiser LLC in the registry?
The most recently registered devices listed for Reckitt Benckiser LLC include KY Personal Lubricant Jelly 00067981089028, KY Personal Lubricant Jelly 00067981089127, KY Warming Jelly 00067981089479 and KY Warming Jelly 00067981089486.