Equate 681131286251Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00681131286251), received between Jul 9, 2025 and Dec 9, 2025 — classified as 2 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE INITIAL REPORT RECEIVED ON OCTOBER 16, 2025, THE CONSUMER STATED THAT THE PRODUCT CAUSED HER RASH. ON THE COMPLETED CONSUMER INFORMATION REPORT (CIR) RECEIVED ON NOVEMBER 11, 2025, THE CONSUMER STATED THAT SHE USED THE TAPE ON HER RIGHT SHOULDER AND BROKE OUT IN A RASH. SHE HAD TO USE TACROLIMUS OINTMENT 0.1%. IT HELPED WITH THE ITCHING AND HELPED TO HEAL THE RASH. CONSUMER CONFIRMED THAT THE SYMPTOMS CORRECTED AFTER SHE STOPPED USING THE PRODUCT.

  Patient problems: Rash

  MAUDE report 23756917 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN THE INITIAL REPORT RECEIVED ON 06/11/2025, THE CONSUMER STATED THAT HE AND HIS SPOUSE WORE THE TAPE ALL DAY AT (B)(6). AFTER REMOVING THE TAPE IN THE SHOWER, THE SPOUSE EXPERIENCED IRRITATION AND A BURNING SENSATION. THE CONSUMER, WHO REPORTED THE EVENT, ALSO NOTED DRYNESS AND DISCOLORATION IN THE AREA WHERE THE ADHESIVE TAPE HAD BEEN APPLIED. CONSUMER REPORTED THAT MEDICAL ATTENTION WAS SOUGHT. THE DOCTOR SAID THAT IT MAY HAVE BEEN A REACTION DUE TO SUN EXPOSURE AND IT LOOKED LIKE A BURN. IN THE COMPLETED CONSUMER INFORMATION REPORT (CIR) RECEIVED ON JULY 18, 2025, THE CONSUMER REPORTED VISITING A WALK-IN CLINIC, WHERE A DOCTOR PRESCRIBED A THREE-DAY COURSE OF STEROIDS. CONSUMER REPORTED THAT THE SYMPTOMS DID NOT CORRECT AFTER HE STOPPED USING THE PRODUCT. CONSUMER STATED THAT THE AREA HAS IMPROVED, BUT TAPE MARK WHERE THE PRODUCT WAS APPLIED REMAINS VISIBLE.

  Patient problems: Burning Sensation; Skin Inflammation/ Irritation

  MAUDE report 22457735 ↗