Equate 681131006743Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00681131006743), received between Sep 23, 2024 and Dec 4, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE INITIAL REPORT RECEIVED ON SEPTEMBER 10, 2025, THE CONSUMER STATES THAT THE PRODUCT CAUSED A BURN AND PEELED HER SKIN. ON THE COMPLETED CIR RECEIVED FROM THE CONSUMER ON NOVEMBER 06, 2025, THE CONSUMER STATES THAT THE BANDAGES BURNED HER SKIN AROUND THE WOUND. THE CONSUMER WENT TO URGENT CARE AND WAS PRESCRIBED ANTIBIOTIC CREAM. IN THE FORM, CONSUMER STATED THE ISSUE WAS WITH THE TAPE AREA AND THAT THE SYMPTOMS CORRECTED AFTER SHE STOPPED USING THE PRODUCT.

  Patient problems: Burning Sensation; Skin Inflammation/ Irritation

  MAUDE report 23714671 ↗
• InjurySep 18, 2025Use of Device Problem; Use of Device Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED BY ASO ON AUGUST 19, 2025, THE CONSUMER STATED THAT HER 5-YEAR-OLD SON USED THE BANDAGES ON HIS LEG AFTER RUBBING IT AGAINST THE POOL EDGE. THE NEXT EVENING, HE WOKE UP SCREAMING IN PAIN. THEY REMOVED THE BANDAGE, AND HE HAS A CHEMICAL BURN, WITH BLISTERS, REDNESS, AND SWELLING IN THE AREA THAT THE BANDAGE PAD PREVIOUSLY COVERED. THE SKIN HAD BEEN RIPPED OFF WHERE THE ADHESIVE WAS. PER THE INITIAL REPORT, THE CONSUMER STATED THAT THE ISSUE WAS WITH THE PAD AND TAPE AREA. HIS DOCTOR AND THE PATIENT'S MOM WERE TRYING TO DETERMINE WHETHER HE WAS ALLERGIC TO SOMETHING IN THE BANDAGE.

  Patient problems: Abrasion; Skin Inflammation/ Irritation

  MAUDE report 23083083 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED BY ASO ON 04/09/2025, THE CONSUMER STATED THAT SHE EXPERIENCED A REACTION TO THE PRODUCT. ON THE COMPLETED CONSUMER INFORMATION REPORT (CIR) RECEIVED ON MAY 6, 2025, THE CONSUMER STATED THAT THE PRODUCT CAUSED HER RED WELTS UNDER AREAS OF THE ADHESIVE AND PAINFUL SORES. THE CONSUMER MENTIONED USING A HEALING BALM FOR SELF-CARE OF THE WOUND. SHE ALSO USED PAPER TAPE WITH A PAD, AS THE DOCTOR ADVISED, TO KEEP THE WOUND COVERED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22100063 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE INITIAL REPORT RECEIVED BY ASO ON (B)(6) 2025, THE CONSUMER STATED THAT SHE USED TWO BANDAGES AND HAD A CHEMICAL/BURN REACTION. ON THE COMPLETED CONSUMER INFORMATION REPORT (CIR) RECEIVED ON 03/07/2025, THE CONSUMER REPORTED THAT TREATMENT WAS REQUIRED. HER DOCTOR INFORMED THAT SHE HAD A REACTION TO THE PRODUCT. THE CONSUMER STATED THAT THE ADHESIVE BURNED HER SKIN AND THAT THE ISSUE WAS WITH THE TAPE AREA.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21691277 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE INITIAL REPORT RECEIVED BY ASO ON 02/19/2025, THE CONSUMER STATED THAT HER HUSBAND HAD A REACTION TO HIS SKIN. HE SAID IT WAS RED AT FIRST, AND NOW IT IS LIKE A BLISTER. HE WENT TO THE DERMATOLOGIST AND HIS DOCTOR WANTED TO SEE THE BANDAGE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21594992 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE INITIAL REPORT RECEIVED BY ASO ON 08/09/2024, THE CONSUMER STATED THAT THE PRODUCT LET HIM THE EXACT SHAPE OF THE BANDAGE, WHICH CAUSED HIM A RED CHEMICAL BURN ON HIS SKIN. ON THE COMPLETED CONSUMER INFORMATION REPORT (CIR) RECEIVED ON 08/29/2024, THE CONSUMER STATES THAT THE PAD PART OF THE BANDAGE LEFT A VERY RED RECTANGLE OVER THE AREA. THE CONSUMER CONSULTED A NURSE PRACTITIONER (PN), WHO TOLD HIM THAT HE PROBABLY HAD AN ALLERGIC REACTION TO THE BANDAGE AND THAT HE SHOULD STOP USING THE PRODUCT. IN ADDITION, THE CONSUMER STATES THAT HE USED 3% HYDROGEN PEROXIDE ON A SWAP TO CLEAN THE WOUND AREA BEFORE APPLYING THE BANDAGE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20287009 ↗