KY Touch 2-in-1 Massage Creme & Pleasure Gel Personal LubricantRecalls & reported problems
RB Health (us) LLC · Personal Lubricant · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00067981962161), received between Aug 27, 2018 and Aug 27, 2018 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Dyspnea1
- Hypersensitivity/Allergic reaction1
- Rash1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
EXTREME ALLERGIC REACTION [HYPERSENSITIVITY] PATIENT HAD HARD TIME WITH BREATHING. [DYSPNOEA] SLIGHT SKIN RASH [RASH]. COUGHING [COUGH]. PHLEGM IN LUNGS [PRODUCTIVE COUGH]. CASE DESCRIPTION: INITIAL REPORT, RECEIVED DATE: 14-AUG-2018. RECEIVED FROM CONSUMER RELATIONS, COUNTRY: UNITED STATES, REFERENCE NO: (B)(4). MEDICAL DEVICE: K-Y TOUCH 2 IN 1 MASSAGE CREME AND PLEASURE GEL. CASE REFERENCE NUMBER US-(B)(6) IS A SPONTANEOUS CASE REPORT SENT BY A CONSUMER WHICH REFERS TO A MALE AGE UNKNOWN. IT WAS REPORTED BY PATIENT'S PARTNER THAT ON AN UNKNOWN DATE, THEIR HUSBAND OF AN UNKNOWN AGE USED K-Y TOUCH 2 IN 1 MASSAGE CREME AND PLEASURE GEL FOR AN UNKNOWN INDICATION. REPORTER STATED THAT THEY RECENTLY PURCHASED THE PRODUCT AND ON AN UNKNOWN DATE, PATIENT HAD AN EXTREME ALLERGIC REACTION WITH HARD TIME BREATHING, COUGHING, PHLEGM IN HIS LUNGS AND SLIGHT SKIN RASH AFTER USING THE PRODUCT. THE CASE WAS DEEMED SERIOUS BECAUSE IT WAS CLASSED AS MEDICALLY SIGNIFICANT. FOLLOW UP HAS BEEN REQUESTED TO OBTAIN FURTHER INFORMATION. THE COMPANY'S ASSESSMENT IS SERIOUS WITH A RELATEDNESS OF POSSIBLE AND UNANTICIPATED. CASE OUTCOME: UNKNOWN.
Patient problems: Dyspnea; Hypersensitivity/Allergic reaction; Rash
MAUDE report 7820426 ↗
Other Lubricant, personal devices
- Astroglide Ultra Gentle Gel 015594011035Biofilm, Inc · Lubricant, Personal1 report
- Trojan™ Lubricants Premium Collection Arouses & Releases™* 00022600959632Church & Dwight CO., Inc. · Lubricant, personal1 report
- Replens™ Long-Lasting Vaginal Moisturizer 00022600001041Church & Dwight CO., Inc. · Lubricant, personal1 report
- KY Warming Jelly 00067981089479Reckitt Benckiser LLC · Lubricant, Personal1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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