Astroglide Ultra Gentle Gel 015594011035Recalls & reported problems
Biofilm, Inc · Astroglide Ultra Gentle Gel is a personal lubricant for penile, vaginal, and/or anal 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 is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. · 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 00015594011035), received between Jul 31, 2019 and Jul 31, 2019 — 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
- Burn, Thermal1
- Burning Sensation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2019Adverse Event Without Identified Device or Use Problem
I HAVE RECENTLY BOUGHT ASTROGLIDE ULTRA GENTLE GEL PERSONAL LUBRICANT AT (B)(6) IN (B)(6) EARLIER THAT WEEK. I HAVE USED THE ASTROGLIDE BRAND IN THE PAST AND HAVE BEEN SATISFIED WITH THE PRODUCT. UPON EXTERNAL VAGINAL APPLICATION OF THIS ONE, I FELT A BURNING SENSATION THAT JOLTED ME AND BROUGHT ME TO TEARS. I TRIED WIPING IT OFF BUT SOON RAN TO SHOWER TO RINSE IT OFF. AFTER THE SHOWER, I DID A QUICK (B)(6) SEARCH OF THE PRODUCT AND NOTED SIMILAR REVIEWS ON THE ASTROGLIDE WEBSITE. ALL OF THE NEGATIVE REVIEWS SEEMED TO REPORT THE SAME PAINFUL BURNING. I ASSUME IT WAS A BAD BATCH AS IT IS ONLY THE MOST RECENT REVIEWS, FROM THE PAST MONTH OR SO, ARE NEGATIVE AND THE REST ARE FINE. THE NEXT MORNING AFTER VAGINAL SEX WITH MY PARTNER, HE NOTED THAT HE ALSO HAD A SLIGHT BURNING SENSATION ON THE BASE OF HIS PENIS. I ALSO HAD A SLIGHT BURNING SENSATION WITHIN MY VAGINAL CANAL. I GUESS THE PRODUCT WAS SO ABSORBANT THAT IT REMAINED ON THE SKIN OVERNIGHT, EVEN AFTER WASHING. PLEASE INVESTIGATE AND REMOVE THIS PRODUCT FROM STORE SHELVES AS SOON AS POSSIBLE. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Burn, Thermal; Burning Sensation
MAUDE report 8847061 ↗
Other Lubricant, Personal devices
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- 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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