Level 1 HL-390Recalls & reported problems

Summary

The FDA's MAUDE database contains 634 adverse event reports that list this exact device (DI 10695085002796), received between Jul 12, 2017 and May 11, 2026 — classified as 1 injury, 633 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (176 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 634 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Device Markings/Labelling Problem

  THE CUSTOMER RETURNED THE DEVICE STATING, ¿THE PUMP HAD BEEN LEAKING INTERNALLY¿; DURING DEVICE EVALUATION IT WAS FOUND THE SERIAL NUMBER LABEL WAS BLURRY. THERE WERE NO PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137065 ↗
• MalfunctionFeb 3, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE SOLUTION FROM THE HOTLINE DEVICE RECIRCULATING SIDE MAY HAVE BROKEN THROUGH INTO THE PATIENT-TUBING SIDE. THE PATIENT REMAINED HOSPITALIZED FOR POST-SURGICAL RECOVERY. THERE WAS NO PATIENT HARM, AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24249042 ↗
• MalfunctionJan 23, 2026Thermal Decomposition of Device; Overheating of Device; Smoking

  IT WAS REPORTED THAT THE DEVICE EMITTED A BURNT SMELL FROM INSIDE THE CASE. REPORTER STATED THE EVENT OCCURRED UPON POWER ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161868 ↗
• MalfunctionNov 26, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE DEVICE DISPLAYED AN OVER TEMPERATURE ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657477 ↗
• MalfunctionNov 12, 2025Fire; Fire

  IT WAS STATED THAT DEVICE WON'T POWER ON DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532478 ↗
• MalfunctionNov 4, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE WAS ALARMING 'CHECK DISPOSABLES' MESSAGE DURING INFUSION. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468085 ↗
• MalfunctionOct 30, 2025Arcing; Arcing

  IT WAS REPORTED THAT THE DEVICE DISPLAY WAS FUNCTIONING INTERMITTENTLY AND AN ELECTRICAL ARCH WAS HEARD DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT. EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED ISSUE, AS THE CONNECTION BETWEEN THE POWER SWITCH AND PRINTED CIRCUIT BOARD (PCB) WAS FOUND TO BE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430035 ↗
• MalfunctionOct 30, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE TEMPERATURE WAS NOT ACCURATE INTERMITTENTLY AND TUBING FELL OFF WHILE THE UNIT WAS ON AND WORKING WHICH CREATED A MESS OF FLUID ON THE FLOOR. THE UNIT WAS NOT DROPPED THERE WAS NO DELAY OF THERAPY. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23428761 ↗
• MalfunctionSep 18, 2025No Audible Alarm; Fluid/Blood Leak; No Audible Alarm; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE DOES NOT ALARM AT OVER TEMPERATURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085636 ↗
• MalfunctionJul 8, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE DEVICE'S OVER TEMP BUTTON WAS NOT WORKING. EVENT OCCURRED DURING PREVENTIVE MAINTENANCE, AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436390 ↗
• MalfunctionJun 24, 2025Degraded; Leak/Splash; Device Sensing Problem; Degraded; Leak/Splash; Device Sensing Problem

  IT WAS REPORTED THAT THE INTERLOCK FAILED. THE EVENT OCCURRED DURING PREVENTIVE MAINTENANCE, AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323615 ↗
• MalfunctionMay 28, 2025No Audible Alarm; Failure to Analyze Signal; No Audible Alarm; Failure to Analyze Signal

  IT WAS REPORTED THAT THE SPEAKER FAILED TO SOUND THE ALARM OF THE DEVICE, REGARDLESS OF WHICH ALARM WAS TRIGGERED. PER REPORTER, THE DEVICE ALSO FAILED THE PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096310 ↗
• MalfunctionMay 28, 2025No Audible Alarm; Alarm Not Visible; No Audible Alarm; Alarm Not Visible

  IT WAS REPORTED THAT ALARMS BESIDES THE BASIC TEST ALARM ARE PRODUCING NOISE OR LIGHT CHANGES WHEN TRIGGERED. HOWEVER, PER REPORTER, THE PUMP DOES STOP. THE ISSUE WAS DISCOVERED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096307 ↗
• MalfunctionMay 23, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT WHEN THEY DISCONNECTED THE FLUID, THEY PUTTING IN THE UNIT WHEN ITS DISCONNECTED THE ALARM THAT'S SUPPOSE TO GO OFF WHEN DISCONNECTED DOES NOT GO OFF OR SOUND-CRACK ON THE TOP OF THE FACEPLATE, MISSING DRAIN CAP DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075829 ↗
• MalfunctionMay 21, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT WHEN THE OPERATOR OF THE DEVICE PRESSED THE BUTTON, IT DID NOT SEEM TO TRIGGER THE ALARM. THE EVENT OCCURRED DURING PREVENTIVE MAINTENANCE. THERE WAS UNKNOWN PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061234 ↗
• MalfunctionMay 15, 2025No Audible Alarm; Alarm Not Visible; Excessive Heating; No Audible Alarm; Alarm Not Visible; Excessive Heating

  IT WAS REPORTED THAT THE OVER TEMPERATURE ALARM SOUND WAS NOT WORKING. NOTHING AUDIBLE, NO BEEPING. PATIENT INVOLVEMENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029965 ↗
• MalfunctionMay 13, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE DEVICE WAS ALARMING OVER TEMPERATURE WHEN RUNNING DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013626 ↗
• MalfunctionMay 13, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE ALARM HAD NO AUDIO. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010008 ↗
• MalfunctionMay 13, 2025Defective Alarm; Circuit Failure; Defective Alarm; Circuit Failure

  IT WAS REPORTED THAT THE DISPOSABLE ALARM WAS NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009999 ↗
• MalfunctionMay 13, 2025No Audible Alarm; Circuit Failure; No Audible Alarm; Circuit Failure

  IT WAS REPORTED THAT THE ALARM HAD NO AUDIO. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009990 ↗
• MalfunctionApr 29, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE REPLACEMENT DEVICE DOES NOT SOUND AN ALARM WHEN THE SIDE ALARM BUTTON IS PRESSED. THE EVENT OCCURRED UPON REMOVAL FROM PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927430 ↗
• MalfunctionApr 23, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE WAS NOT HEATING CORRECTLY. THERE WAS NO DELAY OF THERAPY. THE EVENT OCCURRED DURING SET-UP. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892954 ↗
• MalfunctionApr 1, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT THE ALARM SPEAKER IS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740236 ↗
• MalfunctionMar 28, 2025Failure to Pump; Failure to Pump

  IT WAS REPORTED THAT THE FLUID WARMER FAILED ANNUAL PREVENTATIVE MAINTENANCE (PM) AND THE OVER TEMPERATURE ALARM DOES NOT GO OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21722683 ↗
• MalfunctionMar 28, 2025Failure to Pump; Failure to Pump

  IT WAS REPORTED THAT THE FLUID WARMER FAILED ANNUAL PREVENTATIVE MAINTENANCE (PM) AND THE OVER TEMPERATURE ALARM DOES NOT GO OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21722333 ↗

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-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-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-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
• 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-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-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