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Data / Medical devices / United States / Reckitt Benckiser LLC

Reckitt Benckiser LLC: FDA-registered device maker in Nutley, NJ, United States, 31 510(k) clearances

Reckitt Benckiser LLC is registered with the FDA (registration 3011015568) in Nutley, NJ, United States. It lists 13 device types. The FDA files 31 510(k) clearances under its listings, the newest dated April 8, 2025. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Reckitt Benckiser LLC
FDA registration number
3011015568
Address
100 Metro Blvd, Nutley, NJ, United States, 07110
Owner or operator
Reckitt Benckiser LLC (9004884)
Roles
Complaint file establishment, Specification developer
First device listed
May 23, 2007
Registered through
2026
Brand names listed
Durex 2 in 1 Massage Play Aloe Vera, Durex 2 in 1 Massage Play Guarana, Durex 2 in 1 Massage Play Ylang Ylang, Durex Adventure Pack, Durex Air Close Fit, Durex Air Regular Fit, Durex Cheeky Play Silicone Long Lasting Personal Lubricant, Durex Cheeky Play Silicone Long Lasting Pleasure Personal Lubricant and more

Devices it lists

DeviceProduct codeClassRoleSource
CondomHIS2Complaint file establishmentaccessdata.fda.gov
Condom, SyntheticMOL2Complaint file establishmentaccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Complaint file establishmentaccessdata.fda.gov
Detectors And Removers, Lice, (Including Combs)LJL1Complaint file establishmentaccessdata.fda.gov
Device, External Penile RigidityLKY2Complaint file establishmentaccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Complaint file establishmentaccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Complaint file establishmentaccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Complaint file establishmentaccessdata.fda.gov
Lubricant, PatientKMJ1Complaint file establishmentaccessdata.fda.gov
Lubricant, PersonalNUC2Complaint file establishmentaccessdata.fda.gov
Nasal Spray, Ent DeliveryKCO1Complaint file establishmentaccessdata.fda.gov
Orthosis, Corrective ShoeKNP1Complaint file establishmentaccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Complaint file establishment, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 8, 2025K243967ONE Nitrile CondomMOLSubstantially EquivalentGlobal Protection Corp.accessdata.fda.gov
February 28, 2025K241617Durex Polyisoprene CondomMOLSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
August 23, 2024K240896ONE Nitrile CondomMOLSubstantially EquivalentGlobal Protection Corp.accessdata.fda.gov
August 11, 2023K223519Carex Hybrid Personal LubricantNUCSubstantially EquivalentKarex Industries Sdn. Bhd.accessdata.fda.gov
November 7, 2022K220489Durex Patronus CloseFit, Durex Patronus RegularHISSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
October 12, 2022K222068Durex Penck III RegularHISSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
May 11, 2022K211152Durex Condom with BenzocaineHISSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
March 1, 2022K213400Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play StrawberryNUCSubstantially EquivalentRb Health (Us)accessdata.fda.gov
July 9, 2021K211088Grosz Play FeelNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
July 30, 2020K201186KY Grosz JellyNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
April 20, 2020K193032KY Grosz LiquidNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
April 14, 2020K192982KY Grosz UltraGelNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
May 17, 2019K183505KY Banksy MoistureNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
April 16, 2019K183302KY Banksy AloeNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
January 12, 2018K173504K-Y SiliconeNUCSubstantially EquivalentReckitt Benckiser, LLCaccessdata.fda.gov
January 11, 2016K151884K-Y Marilyn Pleasure GelNUCSubstantially EquivalentReckitt Benckiser, LLCaccessdata.fda.gov
November 8, 2013K122061K-Y BRAND LIQUIBEADSNUCSubstantially EquivalentJohnson & Johnson Healthcare Productsaccessdata.fda.gov
September 27, 2013K122219THEYFIT MALE CONDOMHISSubstantially EquivalentTheyfitaccessdata.fda.gov
December 7, 2011K113061LARGE/EXTRA LAGRE CONDOMHISSubstantially EquivalentKarex Industries Sdn. Bhd.accessdata.fda.gov
February 6, 2009K081886KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATEDHISSubstantially EquivalentKarex Industries Sdn. Bhd.accessdata.fda.gov
June 19, 2008K072169DUREX SYNTHETIC POLYISOPRENE MALE CONDOMMOLSubstantially EquivalentSsl Americas, Inc.accessdata.fda.gov
May 7, 2008K072236DUREX PLAY TINGLING AQUEOUS BASED LUBRICANTNUCSubstantially EquivalentSsl Americasaccessdata.fda.gov
March 10, 2008K063385DUREX PLAY MASSAGE GEL LUBRICANTNUCSubstantially EquivalentSsl Americas, Inc.accessdata.fda.gov
March 6, 2008K072421K-Y BRAND YOURS+MINENUCSubstantially EquivalentMcneil-Ppc, Inc.accessdata.fda.gov
March 23, 2007K070545K-Y BRAND WARMING LIQUIDNUCSubstantially EquivalentPersonal Products Co.accessdata.fda.gov
February 23, 2005K042563DUREX PLAY WARMER LUBRICANTKMJSubstantially EquivalentSsl Americas, Inc.accessdata.fda.gov
April 27, 2004K040185DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOMHISSubstantially EquivalentSsl Americasaccessdata.fda.gov
April 5, 2004K040164K-Y BRAND WARMING JELLY PERSONAL LUBRICANTNUCSubstantially EquivalentPersonal Products Company, Div. of Mcneil-Ppc, Inc.accessdata.fda.gov
June 12, 2002K020827K-Y BRAND ULTRA GEL PERSONAL LUBRICANTNUCSubstantially EquivalentPersonal Products Co., Div. of Mcneil Ppc, Inc.accessdata.fda.gov
June 21, 1996K955648K-Y PERSONAL LUBRICANTHISSubstantially EquivalentOrtho Pharmaceutical Corp.accessdata.fda.gov
April 21, 1981K810310K-Y LUBRICATING JELLYKMJSubstantially EquivalentJohnson & Johnson Professionals, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
December 19, 201881964Class IITerminatedDurex 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 02340-89455-00Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.accessdata.fda.gov
August 6, 201880939Class IITerminatedPolyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).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-lifeaccessdata.fda.gov
July 23, 201880841Class IITerminatedDurex 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 purposThe products failed the filed specification of 1.0kPa for Burst Pressure.accessdata.fda.gov
November 22, 201675829Class IITerminatedDurex Pleasure Pack. 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine.accessdata.fda.gov

Compare with other makers

Updated April 8, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.