Level 1 HL-390-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10695085002826), received between Jul 24, 2024 and May 26, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Device Sensing Problem

  THE DEVICE WAS RETURNED AS IT WAS REPORTED THAT THE UNIT WOULD NOT RECOGNIZE THE CASSETTE AND IT WAS FOUND OUT DURING SELF-TEST. THE COMPLETED INVESTIGATION CONFIRMED THE REPORTED ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279378 ↗
• MalfunctionJan 26, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE DEVICE UNIT DID NOT ALARM DURING THE ALARM TEST AND OVER-TEMPERATURE TEST. THE UNIT DID NOT WARM UP PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177672 ↗
• MalfunctionAug 13, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT WHEN THE DEVICE WAS CONNECTED, IT BLEW A FUSE AND IT IS OLD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795039 ↗
• MalfunctionJul 28, 2025Overheating of Device; Overheating of Device

  THE DEVICE HAD OVERTEMPT. THE EVENT OCCURRED DURING SELF TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637141 ↗
• MalfunctionJun 25, 2025Overheating of Device; Overheating of Device

  IT WAS STATED THAT DEVICE DOES NOT PUMP-THEN OVERHEATS DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332178 ↗
• MalfunctionApr 28, 2025Pumping Problem; Temperature Problem; Pumping Problem; Temperature Problem

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A HIGH TEMPERATURE. THERE WAS NO INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921470 ↗
• MalfunctionMar 25, 2025Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT THE DEVICE FAILED THE PREVENTATIVE MAINTENANCE (PM) TEST. OVER TEMPERATURE TEST FAILED AND SCREEN FLICKERS. STATUS OF THE PRODUCT AT TIME OF EVENT WAS DURING ROUTINE PREVENTIVE MAINTENANCE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691501 ↗
• MalfunctionSep 19, 2024Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings; Temperature Problem; Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings; Temperature Problem

  IT WAS REPORTED THAT THE DISPLAY WAS ERRATIC. WHEN THE LID WAS OFF, IT WENT BLANK AND GLITCHED. IT HAD ERRATIC TEMPERATURE READINGS. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258683 ↗
• MalfunctionJul 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING WATER NEAR THE CONNECTION WHERE YOU PUT THE TUBING SET. THE EVENT OCCURRED DURING PREVENTIVE MAINTENANCE INSPECTION IN THE BIOMED SHOP. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822392 ↗

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-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-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-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-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-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-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