Level 1 HL-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 991 adverse event reports that list this exact device (DI 50695085820909), received between Nov 7, 2017 and Aug 24, 2026 — classified as 991 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (167 reports).

11 other recalls cover devices cleared under the same FDA submission (K911383); they may or may not involve this specific model.

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 25 most recent of 991 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50419551 ↗
• MalfunctionJul 8, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25752615 ↗
• MalfunctionMay 18, 2026Fire

  IT WAS REPORTED THAT A FIRE OCCURRED WITHIN THE DEVICE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25201227 ↗
• MalfunctionMar 17, 2026Electrical Power Problem

  THE UNIT WAS RETURNED BECAUSE THE UNIT HAD TRIPPED THE LIM (ELECTRICAL SAFETY ALARM) ALARM DUE TO HIGH ELECTRICAL OUTPUT, AND THERE WAS NO ERROR CODES APPEARED. IT HAD OCCURRED DURING SETUP. THE RESULTS OF THE INVESTIGATION FOUND THAT THE DEVICE HAD A CONFIRMED ELECTRICAL ISSUE AND RELATED TO THE MOTOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616514 ↗
• MalfunctionMar 16, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DISTILLED WATER SYSTEM CONTAINED BLOOD AND THE TRANSPARENT COVER WAS CRACKED. THE EVENT WAS NOTICED IN THE TRAUMA SURGERY OPERATING ROOM. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605183 ↗
• MalfunctionMar 3, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE POWER SWITCH WAS FAULTY AND THERE WERE BURNS ON THE PINS. THE POWER CORD AND FRONT CASE OF THE PUMP WAS LOOSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496161 ↗
• MalfunctionFeb 23, 2026Melted

  IT WAS REPORTED THAT THE UNIT SMELLS LIKE PLASTIC WHEN TUNED ON, THE TRACES ON THE MAIN BOARD HAVE MELTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414181 ↗
• MalfunctionFeb 4, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE DEVICE WAS NOT MAINTAINING TEMPERATURE. DURING INVESTIGATION IDENTIFIED DAMAGE TO THE DEVICE SERIAL NUMBER LABEL, THEREFORE MAKING THIS INVESTIGATION REPORTABLE. THE EVENT HAD OCCURRED DURING ROUTINE PREVENTIVE MAINTENANCE INSPECTION AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258287 ↗
• MalfunctionJan 6, 2026Break; Electrical /Electronic Property Problem

  THE CUSTOMER RETURNED THE DEVICE STATING, ¿THE OUTLET WAS BROKEN¿; DURING DEVICE EVALUATION IT WAS FOUND THE AC PLUG BLADE WAS BROKEN AND BURN MARKS WERE FOUND. THE EVENT OCCURRED DURING PRIMING AT THE FACILITY. THERE WAS NO REPORTED PATIENT INVOLVEMENT/HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975682 ↗
• MalfunctionDec 8, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE DEVICE HAD LOW TEMPERATURE READING AND NO AUDIBLE ALARM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751478 ↗
• MalfunctionNov 20, 2025Temperature Problem; Excessive Heating; Temperature Problem; Excessive Heating

  IT WAS REPORTED THAT THE FLUID WARMER TEMPERATURE DISPLAY WENT UP TO 44 DEGREES. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610373 ↗
• MalfunctionNov 13, 2025Device Alarm System; Temperature Problem; Device Alarm System; Temperature Problem

  IT WAS REPORTED THAT THERE IS A TEMPERATURE ALARM OCCURRED IN THE SURGERY ROOM. THERE WAS A THERAPY DELAY, AND THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544463 ↗
• MalfunctionNov 6, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DEVICE HAS FLUCTUATING TEMPERATURE DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23492951 ↗
• MalfunctionNov 3, 2025Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT DEVICE GAVE A BURNING SMELL AND WAS SMOKING. REPORTER STATED THAT THE PRODUCT WOULD NOT POWER ON AND STATED THAT A BURNT COMPONENT WAS OBSERVED ON THE BOARD DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450875 ↗
• MalfunctionOct 30, 2025Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT THE DEVICE HAD NO AUDIBLE ALARM. DURING TESTING, IT WAS FOUND THAT THERE WAS NO AUDIBLE SOUND. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424404 ↗
• MalfunctionOct 28, 2025Device Alarm System; No Audible Alarm; Device Alarm System; No Audible Alarm

  IT WAS REPORTED THAT THE ALARM DID NOT ACTIVATE DURING PRIMING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405873 ↗
• MalfunctionOct 28, 2025No Audible Alarm; Temperature Problem; No Audible Alarm; Temperature Problem

  IT WAS REPORTED THAT THERE WERE NO ALARMS ON, UNLESS THE DISPLAY TEMP REACHES ABOVE 43.1 CELSIUS. THE EVENT OCCURRED DURING PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402843 ↗
• MalfunctionOct 15, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING AND HAD FRAYED WIRES ON THE POWER CORD. THE EVENT OCCURRED UPON POWER ON. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279291 ↗
• MalfunctionSep 8, 2025False Alarm; False Alarm

  IT WAS REPORTED THAT THE DEVICE DETECTS LOW WATER LEVEL EVEN IS FULLY FILLED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992202 ↗
• MalfunctionAug 25, 2025Fluid/Blood Leak; Failure to Infuse; Fluid/Blood Leak; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE HAS TEMPERATURE ISSUES ALARM 69-DEGREE CELSIUS AND LEAKING DURING POWER ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891195 ↗
• MalfunctionAug 19, 2025Inaccurate Information; Inaccurate Information

  THE SCREEN ON THIS UNIT WAS DISPLAYING ¿06¿ WHILE RUNNING. AS IN THE SCREEN NEVER CHANGES EVEN THOUGH THEY CAN VALIDATE THE TEMPERATURE WAS CHANGING. THE EVENT OCCURRED DURING ROUTINE PREVENTIVE MAINTENANCE INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843015 ↗
• MalfunctionAug 13, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE HANDLE OF THE POLE CLAMP WAS BROKEN AND THE HEAT TEST ALARM DOES NOT WORK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22797618 ↗
• MalfunctionAug 12, 2025Failure to Recalibrate; Calibration Problem; Failure to Recalibrate; Calibration Problem

  IT WAS REPORTED THAT THE DEVICE WOULD NOT CALIBRATE. THE NORMAL TEMPERATURE WOULD NOT ADJUST. THE EVENT OCCURRED DURING PREVENTIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784861 ↗
• MalfunctionAug 12, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE DEVICE WOULD NOT CALIBRATE. THE NORMAL TEMP WOULD NOT ADJUST. THE EVENT OCCURRED DURING PREVENTIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784483 ↗
• MalfunctionAug 12, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT WHEN POWERING, THE UNIT ON IT KEEPS BEEPING. THE ISSUE OCCURRED DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783791 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K911383. One submission often covers many models, so check the product and lot details in each record.

• Z-2759-2026 · Jun 24, 2026 · Open, Classified
  Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperature
• Z-1444-2014 · Mar 17, 2014 · Terminated
  Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity condit
• Z-1443-2014 · Mar 17, 2014 · Terminated
  Smiths Medical HOTLINE Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditio
• Z-1979-2012 · Jun 27, 2012 · Terminated
  Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE 3 Blood and Fluid Warmer. This product, for use in
• Z-0423-2012 · Nov 21, 2011 · Terminated
  HOTLlNE Disposable Administration Sets, Product Codes L-70NI Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE
• Z-0428-2012 · Nov 21, 2011 · Terminated
  Level 1 Normothermic I.V. Fluid Administration Sets, Product Code DI-60HL , Product Usage: Single patient use sets designed for use by trained medical professionals, in conjuncti
• Z-0424-2012 · Nov 21, 2011 · Terminated
  HOTLlNE Disposable Administration Sets, Product Code L-270 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE
• Z-0425-2012 · Nov 21, 2011 · Terminated
  HOTLlNE Disposable Administration Sets, Product Code L-370 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE
• Z-0427-2012 · Nov 21, 2011 · Terminated
  Level 1 Normothermic I.V. Fluid Administration Sets, Product Code D-60HL , Product Usage: Single patient use sets designed for use by trained medical professionals, in conjunctio
• Z-0426-2012 · Nov 21, 2011 · Terminated
  HOTLlNE Disposable Administration Sets, Product Code L-80 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE R
• Z-0422-2012 · Nov 21, 2011 · Terminated
  HOTLlNE Disposable Administration Sets, Product Codes L-70 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE R