WarmTouchRecalls & reported problems across all models

We found 5 models of WarmTouch by Covidien LP in the FDA's device registry (GUDID). Together they are named in 89 adverse event reports in the FDA's MAUDE database, received between Jan 5, 2018 and Sep 30, 2026 — classified as 5 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (35 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported WarmTouch problems

WarmTouch models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• WarmTouch 5016000

  System, thermal regulating
  82 reports
• WarmTouch 5030850

  System, thermal regulating
  2 reports
• WarmTouch 5030810

  System, thermal regulating
  2 reports
• WarmTouch 5030870

  System, thermal regulating
  2 reports
• WarmTouch 5016000-RC

  System, thermal regulating
  1 report

Recent WarmTouch adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Temperature Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954957 ↗
• MalfunctionSep 25, 2026Temperature Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904134 ↗
• MalfunctionMay 4, 2026High Readings

  IT WAS REPORTED THAT THE TEMPERATURE OF THE WARMING UNIT WAS INCREASING AND THEN STOPPED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074346 ↗
• MalfunctionApr 1, 2026Image Display Error/Artifact; Temperature Problem

  IT WAS REPORTED THAT, DURING SERVICING, THE WARMING UNIT HAD A YELLOW TRIANGLE ALARM. THERE WAS NO SMOKE OR FIRE. THE INTERNAL CONNECTORS AND CABLES WERE PHYSICALLY BURNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760622 ↗
• InjuryAug 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE BLANKET WAS FUNCTIONING CORRECTLY PRIOR TO AND DURING THE PROCEDURE. THE PATIENT WAS LAID ON TOP OF THE BLANKET, INSTEAD OF THE BLANKET BEING DRAPED ON TOP OF THE PATIENT. THEN THE PATIENT URINATED ONTO THE BLANKET, WHICH CAUSED BURNS ON THE PATIENT'S BUTTOCKS. THE BLANKET TEMPERATURE WAS SET TO 42 DEGREES CELSIUS HALFWAY THROUGH TO 38 DEGREES CELSIUS AND WAS WITH THE PATIENT FOR TWO HOURS AND 30 MINUTES. THERE WERE NO SIGNS OF BURNS AFTER THE PROCEDURE AND NOTICED THE FOLLOWING DAY. THE PATIENT WAS REFERRED TO PLASTICS, AND THE WOUND WAS CLEANED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22771418 ↗
• MalfunctionJul 8, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT WHEN THE DEVICE WAS PLUGGED IN, THERE WAS A SMOKE ODOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22441510 ↗
• MalfunctionJun 30, 2025Device Alarm System; High Readings; Device Alarm System; High Readings

  IT WAS REPORTED THAT DURING USE, THE UNIT WAS REACHING AROUND 55°C DESPITE BEING SET TO 40°C. THE SYSTEM DID NOT DISPLAY ANY ERROR OR WARNING. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22355288 ↗
• MalfunctionJun 30, 2025Device Alarm System; High Readings; Patient Device Interaction Problem; Device Alarm System; High Readings; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING USE, THE UNIT WAS REACHING AROUND 55°C DESPITE BEING SET TO 40°C. THE SYSTEM DID NOT DISPLAY ANY ERROR OR WARNING, WHICH RESULTED IN BURNS TO THE PATIENT.

  Patient problems: Skin Burning Sensation

  MAUDE report 22355264 ↗
• MalfunctionJun 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING USE, THE UNIT EXHIBITED INCREASED HEAT, RESULTING IN A BURN INJURY TO THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 22352687 ↗
• MalfunctionJun 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, DURING USE, THE UNIT HAD AN INCREASED HEAT CAUSING A BURN TO THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 22352669 ↗
• MalfunctionJun 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING USE, THE UNIT EXHIBITED INCREASED HEAT, RESULTING IN A BURN INJURY TO THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 22352668 ↗
• MalfunctionJun 17, 2025Device Damaged Prior to Use; Defective Component; Component Missing; Temperature Problem; Device Damaged Prior to Use; Defective Component; Component Missing; Temperature Problem

  IT WAS REPORTED THAT THE DEVICE HAD A BROKEN CASING, MISSING NOZZLE, AND THE POWER SUPPLY WAS BURNT. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22243905 ↗
• MalfunctionMay 19, 2025Image Display Error/Artifact; High Readings; Image Display Error/Artifact; High Readings

  IT WAS REPORTED THAT A HIGH TEMPERATURE ERROR WAS OBSERVED WITH THE UNIT. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COM PLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22044330 ↗
• MalfunctionMay 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE WAS A PATIENT BURN OCCURRED DUE TO THE BLANKET WITH 45" IN THE RECOVERY ROOM. THERE WERE TEMPERATURE MANAGEMENT DEVICES FROM VARIOUS MANUFACTURERS IN THE ROOM, IT WAS UNCLEAR WHICH DEVICE CAUSED THE BURN.

  Patient problems: Burn(s)

  MAUDE report 22043450 ↗
• MalfunctionMar 17, 2025Insufficient Heating; Image Display Error/Artifact; Device Damaged Prior to Use; Temperature Problem; Insufficient Heating; Image Display Error/Artifact; Device Damaged Prior to Use; Temperature Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE SHOWED A YELLOW TRIANGLE ALARM 10 MINUTES AFTER BEING TURNED ON, DID NOT HEAT THE AIR, AND ALSO HAD DAMAGED CARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21622852 ↗

Other Covidien LP products

• Endo GIA48 models · 26,277 reports · 8 recalls
• Endo GIA Ultra3 models · 15,650 reports
• Shiley387 models · 9,392 reports · 5 recalls
• Signia16 models · 8,201 reports · 6 recalls
• LigaSure32 models · 7,283 reports · 1 recall
• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
• Polysorb291 models · 4,564 reports · 2 recalls
• EEA39 models · 4,432 reports · 1 recall