Level 1 HL-90-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 50695085821098), received between May 18, 2022 and Sep 1, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2023Break; No Display/Image; Break; No Display/Image

  IT WAS REPORTED THAT THE TEMPERATURE DISPLAY WAS DAMAGED. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17674136 ↗
• MalfunctionMay 18, 2022Failure to Calibrate; Excessive Heating; Failure to Calibrate; Excessive Heating

  IT WAS REPORTED THAT THE FLUID WARMING DEVICE HAD AN OUT OF BOX FAILURE. THE DEVICE BEGAN TO OPERATE OVER-TEMPERATURE AND COULD NOT BE CALIBRATED. NO PATIENT WAS INVOLVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428810 ↗

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-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-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-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-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