Freeze Away Skin Tag Remover 90000415Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888853003467), received between May 19, 2023 and Dec 2, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 05-NOV-2024, THIS SPONTANEOUS REPORT WAS RECEIVED VIA A LETTER REGARDING A 64-YEAR-OLD FEMALE CONSUMER FROM THE UNITED STATES IN ASSOCIATION WITH THE DR. SCHOLL'S COMPLETE CARE SKIN TAG REMOVER. ON (B)(6) 2024, THE CONSUMER USED THE DR. SCHOLL'S COMPLETE CARE SKIN TAG REMOVER TO HER RIGHT NECK, LEFT SHOULDER NEAR THE NECKLINE, AND TO AN UNDERARM. AFTER USING THE PRODUCT, THE CONSUMER EXPERIENCED BURNS, REDNESS, AND SKIN DISCOLORATION ON HER RIGHT NECK, ON HER LEFT SHOULDER NEAR THE NECKLINE, AND ON AN UNDERARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 20826007 ↗
• InjuryFeb 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 18-JAN-2024, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL REGARDING A 63-YEAR-OLD MALE WHO USED A DR. SCHOLLS FREEZE AWAY SKIN TAG REMOVER. ON AN UNSPECIFIED DATE IN (B)(6) 2023, REPORTED AS 6 MONTHS AGO (RELATIVE TO (B)(6) 2024), THE CONSUMER'S WIFE TOPICALLY APPLIED THE DR. SCHOLLS FREEZE AWAY SKIN TAG REMOVER TO HIS LOWER BACK SKIN TAG AS HE COULD NOT SEE THE AREA PROPERLY. THE SKIN TAG DID NOT FREEZE OR FALL OFF AFTER APPLICATION OF THE PRODUCT. THE DAY AFTER APPLICATION HE COULD SEE A LITTLE BUMP IN THE MIRROR AT THE APPLICATION SITE AND IT WAS SORE TO THE TOUCH. AFTER A COUPLE OF DAYS, THE BUMP RAISED MORE. IT WAS RED AND IT PROTRUDED FROM THE SKIN MORE THAN BEFORE. AFTER 1 TO 2 WEEKS THE AREA STARTED OOZING AND HE BELIEVED IT WAS INFECTED, BUT HE DID NOT SHOW IT TO HIS DOCTOR. AFTER A MONTH, IT WAS NOTED TO BE BIGGER AND A SIZE OF A MARBLE. IT KEPT GROWING. APPROXIMATELY 4 MONTHS AFTER APPLICATION, THE CONSUMER VISITED HIS DOCTOR. THE CONSUMER THOUGHT IT SEEMED LIKE THERE WAS FLUID UNDER THE BUMP. HE RECEIVED A REFERRAL TO AN ONCOLOGIST SURGEON. ON (B)(6) 2023, THE CONSUMER HAD THE GROWTH REMOVED FROM HIS BACK AND A BIOPSY WAS TAKEN. THE SIZE OF THE

  Patient problems: Cancer; Erythema; Fluid Discharge; Pain

  MAUDE report 18704361 ↗
• InjuryMay 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2023, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL REGARDING A CONSUMER (AGE AND SEX NOT PROVIDED). ON AN UNSPECIFIED DATE, THE CONSUMER USED DR. SCHOLLS FREEZE AWAY SKIN TAG REMOVER FOR SKIN TAGS. THE DETAILS OF HOW THE CONSUMER USED THE DEVICE WERE NOT PROVIDED. ON AN UNSPECIFIED DATE AFTER STARTING TO USE THE DEVICE, THE CONSUMER EXPERIENCED HER SKIN BURNING, SWELLING, AND BLEEDING. SUBSEQUENTLY, SHE WENT TO HER DOCTOR. THE CONSUMER NOTED THAT SHE HAD SECOND DEGREE BURNS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16965594 ↗