Skip to content

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.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue71

Newest first, rows 51-71 of 71

Search and filter all 71 devices
Skip device list

Rows 51-71 of 71

Showing 51-71 of 71

Company details

FDA FEI number
3011015568
Address
100 Metro Blvd, Nutley, NJ, 07110

FDA recalls5

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 4
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

1 initiated before 2017

  • 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. Distribution: Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten. Submission number: K072169
    • 19 Dec 2018 Z-0994-2019 Class II Terminated Five batches of the product have failed the specification of 1.0kPa for Burst Pressure. Distribution: Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten. Submission number: K072169
    • 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 Distribution: US in the states of NY Submission number: K072169
    • 23 Jul 2018 Z-3241-2018 Class II Terminated The products failed the filed specification of 1.0kPa for Burst Pressure. Distribution: US Nationwide. Submission number: K072169

  • 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. Distribution: Nationwide and Foreign

This is an FDA establishment record. No EUDAMED registration is known for this company.