Mabis 40-741-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00767056407411), received between Dec 22, 2025 and Apr 30, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Excessive Heating” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Excessive Heating

  MDR NUMBER:1000143485-2025-28077 ADDITIONAL MANUFACTURER NARRATIVE REACHED OUT TO CUSTOMER, ON MULTIPLE OCCASIONS REQUESTING ADDITIONAL INFORMATION. PHOTOS WERE RECEIVED OF UNIT AND NO DAMAGE WAS OBSERVED INDICATING UNIT DID NOT EXPLODE BUT THAT HOT WATER POPPED. EVENT OR PROBLEM DESCRIPTION CUSTOMER INDICATED WHILE THEY WERE USING THE UNIT IT EXPLODED AND HOT WATER LANDED ON HER CHIN CAUSING A BURN.

  Patient problems: Burn(s)

  MAUDE report 25039891 ↗
• InjuryDec 22, 2025Inadequate User Interface; Misassembly by Users; Excessive Heating; Inadequate User Interface; Misassembly by Users; Excessive Heating

  MDR NUMBER:1000143485-2025-28077 ADDITIONAL MANUFACTURER NARRATIVE REACHED OUT TO CUSTOMER, ON MULTIPLE OCCASIONS REQUESTING ADDITIONAL INFORMATION. PHOTOS WERE RECEIVED OF UNIT AND NO DAMAGE WAS OBSERVED INDICATING UNIT DID NOT EXPLODE BUT THAT HOT WATER POPPED. EVENT OR PROBLEM DESCRIPTION. CUSTOMER INDICATED WHILE THEY WERE USING THE UNIT IT EXPLODED AND HOT WATER LANDED ON HER CHIN CAUSING A BURN. CAUSE ANALYSIS. 5.1. ACCORDING TO THE CUSTOMER COMPLAINT INFORMATION QUERY, THE PRODUCTION DATE OF THE CUSTOMER COMPLAINT PRODUCT IS NOVEMBER 26, 2021, AND IT HAS BEEN IN PRODUCTION FOR 4 YEARS, WHICH HAS EXCEEDED THE PRODUCT'S SERVICE LIFE. 5.2.AS THE DEFECTIVE PRODUCTS WERE NOT RETURNED, VEGA CONDUCTED A POSSIBLE CAUSE ANALYSIS AND VERIFICATION BASED ON THE CUSTOMER'S DESCRIPTION. 5.2.1. ACCORDING TO THE INSTRUCTIONS, ONLY 25ML OF CLEAR WATER SHOULD BE ADDED TO THE HEATING CUP EACH TIME, AND 60ML OF CLEAR WATER SHOULD BE ADDED TO THE COLD-WATER TANK. SIMULATE WHETHER THERE IS HOT WATER SPURTING OUT AND SCALDING THE USER WHEN THE CONSUMER ADDS MORE THAN 25ML OF CLEAR WATER TO THE HEATING CUP OR FILLS IT UP. 5.2.1.1 SIMULATION VERIFICATION: FILL THE HEATING CUP WITH CLEAR WATER (ABOUT

  Patient problems: Blister; Burn(s); Skin Discoloration

  MAUDE report 23864708 ↗