Lubricant, Personal
Obstetrics/Gynecology · 21 CFR 884.5300
This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.
Recent MDR events
171 adverse event reports on file
- ÜberlubeJul 27, 2026InjuryUberlube, Inc.3012482333-2026-00001
- XESSO WATER-BASED CREAMY LUBEJun 29, 2026MalfunctionUnknownMW5190002
- K-Y WARMING LIQUID SENSORIAL PERSONAL LUBRICANTJun 26, 2026InjuryReckitt BenckiserMW5189914
- K-Y WARMING LIQUID SENSORIAL PERSONAL LUBRICANTJun 26, 2026InjuryReckitt BenckiserMW5189915
- JO WARMING H2O PERSONAL LUBRICANTSJun 23, 2026InjuryCc Wellness Llc.MW5189798
- JO WARMING H2O PERSONAL LUBRICANTSJun 23, 2026InjuryCc Wellness LlcMW5189799
- KY WARMING LUBEApr 29, 2026InjuryUnkMW5187426
- KY WARMING LUBEApr 29, 2026InjuryUnkMW5187427
- JELLY PERSONAL LUBRICANTApr 22, 2026InjuryEquate/walmart StoresMW5187173
- LUXE WATER-BASED PERSONAL LUBRICANTDec 23, 2025OtherHathor Professional Skincare Ltd.MW5181125
Event type breakdown
Recalls
7 recall events for this product code
- Family Dollar Stores, Llc.Open, ClassifiedAug 17, 2022
KY JELLY LUBRICANT 2 FL OZ, SKU 901443
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Z-1547-2022 · View FDA record ↗ - Mc-NEIL-PPC, Inc.TerminatedFeb 22, 2013
KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
This product is not cleared for marketing in the US.
Z-0873-2013 · View FDA record ↗ - Mc-NEIL-PPC, Inc.TerminatedFeb 22, 2013
KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by M
This product is not cleared for marketing in the US.
Z-0874-2013 · View FDA record ↗ - Mc-NEIL-PPC, Inc.TerminatedFeb 22, 2013
KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.
This product is not cleared for marketing in the US.
Z-0875-2013 · View FDA record ↗ - Mc-NEIL-PPC, Inc.TerminatedSep 27, 2012
KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958.
Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device application. This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y LIQUIBEADS. JJHP received a Warning Letter on May 23, 2012 indicating that thi
Z-2467-2012 · View FDA record ↗ - Memphis Fertility Laboratory IncTerminatedAug 27, 2009
ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN
Product was marketed without a 510(k).
Z-1904-2009 · View FDA record ↗ - INGfertility, LLCTerminatedJan 23, 2009
Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant.
Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).
Z-0626-2009 · View FDA record ↗
Registered firms
343 firms currently registered for this product code
Cc Wellness Llc
Valencia, CA, US
Combe Incorporated
White Plains, NY, US
Lvliang Lishi District Wenfeng Trade Co., Ltd.
Lvliang Shanxi, CN
Ssl Manufacturing (thailand) Ltd.
BANGSAMAK,BANGPAKONG Chachoengsao, TH
Global Protection Corp.
Lynn, MA, US
Wisconsin Pharmacal Co., Llc
JACKSON, WI, US
Karex Industries Sdn Bhd
PONTIAN Johor, MY
Applied Laboratories, Inc.
COLUMBUS, IN, US
Valencia Naturals, Inc
Chatsworth, CA, US
The Kama Sutra Company
Moorpark, CA, US
The Honey Pot Company Llc
Atlanta, GA, US
Lovehoney Group Germany Gmbh
Berlin, DE
Md Labs, Llc
Westlake Village, CA, US
Good Clean Love, Inc.
Eugene, OR, US
Westridge Laboratories, Inc
Santa Ana, CA, US
Yiwu Nianxun E-commerce Co., Ltd.
Jinhua Zhejiang, CN
Private Label Productions, Llc
Bonita Springs, FL, US
510(k) clearances
247 clearances for this product code
- Bumlicious, LLC (DBA Bumlicious)Aug 7, 2026
K261905 · BUM Oil
- PINKSLIP, LLCJul 9, 2026
K261177 · PINKSLIP Water-Based Personal Lubricant and Moisturizer
- PCCA, Inc.Jul 6, 2026
K261909 · Plum Vagiceuticals Vaginal Moisturizing Suppositories
- LBDO Group, Inc.Jun 22, 2026
K254011 · Flow Water-Based Personal Lubricant
- PR Personal Care LaboratoriesJun 11, 2026
K261292 · PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)
- Hathor Professional Skincare , Ltd.Jun 9, 2026
K252914 · Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
- Pjur Group Luxembourg S.A.May 21, 2026
K260068 · pjur NATURE Touch, 100 ml
- Golden Isles Medical, Inc.Apr 16, 2026
K254101 · Julva Velvé Water-Based Personal Lubricant