Diolaze XL 810 Applicator AG605985ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290016633269), received between Feb 20, 2023 and Feb 20, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT STATES THAT HE HAS A BURN IN GENITALS AREA AFTER DIOLAZEXL TREATMENT. HE WENT TO A COSMETIC PLASTIC SURGEON AND AN EMERGENCY ROOM DOCTOR THAT REPORTEDLY STATED THAT HE HAS IRREPARABLE DAMAGE AND WILL REQUIRE RECONSTRUCTIVE SURGERY. NO PHOTOS OR ANY OTHER MEDICAL RECORDS WERE RECEIVED AS OF 02/19/2023.

  Patient problems: Localized Skin Lesion

  MAUDE report 16402955 ↗