Henry Schein 4990813Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10304040037116), received between Dec 19, 2025 and Dec 19, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Device Handling 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. How this data works · Data updated Oct 13, 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.

• InjuryDec 19, 2025Device Handling Problem; Device Handling Problem

  A 40-YEAR-OLD FEMALE PATIENT WAS UNDERGOING CAPILLARY BLOOD COLLECTION WHEN A HOT PACK WAS APPLIED TO WARM THE SKIN. FOR THE FIRST 30 SECONDS, THE HOT PACK WAS PLACED DIRECTLY ON THE SKIN, AFTER WHICH A CLOTH WAS USED AS A BARRIER FOR THE REMAINING DURATION, TOTALING APPROXIMATELY TWO MINUTES OF APPLICATION. AS A RESULT, THE PATIENT SUSTAINED A SECOND-DEGREE BURN ON THE LEFT UPPER ARM AND A FIRST-DEGREE BURN ON THE RIGHT UPPER ARM, REQUIRING FIRST AID TREATMENT. THERE WAS NO LEAKAGE FROM THE PRODUCT ONTO THE PATIENT. THE BURNS HAVE SINCE HEALED.

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

  MAUDE report 23849496 ↗