Zerigo Handheld System HD-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00865522000415), received between Dec 19, 2025 and Feb 23, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 23, 2026Use of Device Problem; Patient Device Interaction Problem

  THE MEMBER REACHED TO ZERIGO SUPPORT TEAM "MY CHIN WAS TREATED WITH 10 SQUARES (TEN PUSH DOWNS AND RELEASES). ABOUT 10 MINUTES AFTER THE TREATMENT MY CHIN WAS VERY WARM AND HAD A STINGING SENSATION. THE BLISTERING AND OOZING STARTED TO OCCUR ON FRIDAY EVENING (THE DAY OF TREATMENT). THE AREA IS STILL RED AND OOZING TODAY. THE SKIN ON MY CHIN IS TENDER AND SOMETIMES ITCHY."

  Patient problems: Discomfort; Erythema; Partial thickness (Second Degree) Burn; Purulent Discharge

  MAUDE report 24420654 ↗
• InjuryDec 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEMBER STATED THAT THEY EXPERIENCED FIRST- AND SECOND-DEGREE BURNS. MEMBER STATED: "AFTER MY FIRST TREATMENT IT WAS THE NEXT DAY AND I STATED NOTICING BLISTERING AND HAVING LOTS OF PAIN. I FINALLY WENT INTO A WALK IN CLINIC YESTERDAY BECAUSE I HAD ALL THESE OPEN AREAS ON MY CHEST AND ABDOMEN AND THEY WERE DRAINING AN AWFUL SMELLY DISCHARGE FROM THEM. THE DR SAID I HAVE SECOND DEGREE BURNS SO I'M TAKING AN ANTIBIOTIC AND I SEE THE DERMATOLOGIST TOMORROW MORNING."

  Patient problems: Pain; Partial thickness (Second Degree) Burn; Skin Discoloration; Superficial (First Degree) Burn

  MAUDE report 23858180 ↗