Level 1 L-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 40695085401002), received between Apr 5, 2018 and Dec 18, 2025 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (28 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD LEAKED DURING USE. THE EVENT OCCURRED DURING PATIENT ADMINISTRATION AT THE FACILITY. NO PATIENT HARM OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838023 ↗
• MalfunctionNov 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD LEAKED DURING USE. THE EVENT OCCURRED DURING PATIENT ADMINISTRATION AT THE FACILITY. NO PATIENT HARM OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510401 ↗
• MalfunctionOct 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LIQUID WAS LEAKING FROM THE FILTER. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494220 ↗
• MalfunctionSep 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD LEAKED FROM THE RUBBER VALVES. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20215955 ↗
• MalfunctionJul 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PRIMING, THE DEVICE WAS LEAKING FROM THE FILTER. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19741718 ↗
• MalfunctionJun 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "LIQUID LEAKAGE FROM THE FILTER PART." THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458472 ↗
• MalfunctionSep 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE IS USE WITH A PATIENT, THERE WAS A BLOOD LEAK. THE BLOOD LEAKAGE OCCURRED WHEN THE HOTLINE GAS VENT WAS USED. ADVERSE EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17837258 ↗
• MalfunctionMar 21, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT BEFORE OPENING THE PACKAGE, THE CUSTOMER NOTICED THE CONNECTOR WAS DAMAGED. NO BROKEN PIECE WAS FOUND IN THE PACKAGE. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587918 ↗
• MalfunctionMar 21, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CONNECTOR BROKE OFF. NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585278 ↗
• MalfunctionMar 21, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CONNECTOR BROKE OFF. NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584897 ↗
• MalfunctionMar 21, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CONNECTOR WAS FOUND DAMAGED. NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582995 ↗
• MalfunctionNov 4, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, LEAKAGE OF FLUID FROM IT WAS OBSERVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15735375 ↗
• MalfunctionOct 23, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE, THE CUSTOMER NOTICED THE CONNECTION PART WAS DAMAGED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656414 ↗
• MalfunctionOct 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DEVICE HAD A LEAK FROM THE LUER CONNECTOR. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12650257 ↗
• MalfunctionAug 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE GAS VENT WAS LEAKING FLUID FROM THE FILTER. THE PRODUCT PROBLEM WAS OBSERVED DURING PATIENT USE. THE PRODUCT FAULT DID NOT CAUSE OR CONTRIBUTE TO ANY ADVERSE PATIENT HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362806 ↗
• MalfunctionJul 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED A SMITHS MEDICAL FLUID WARMING/LEVEL 1 HOTLINE ACCESSORIES MALFUNCTIONED. DURING THE USE OF THE PRODUCT, LEAKAGE OF FLUID FROM THE AIR VENT FILTER WAS OBSERVED. SO THE CUSTOMER STOPPED USING IT. THE EXACT USAGE TIME WAS NOT CERTAIN, BUT THE PRODUCT MAY HAVE BEEN USED FOR MORE THAN 3 HOURS. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12199487 ↗
• MalfunctionMay 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  INVESTIGATION COMPLETED AND SUMMARY IN H 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11851729 ↗
• MalfunctionMay 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  INVESTIGATION COMPLETED AND SUMMARY IN H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11851444 ↗
• MalfunctionMay 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE GAS VENT WAS LEAKING FLUID FROM THE FILTER. THE PRODUCT PROBLEM WAS OBSERVED DURING PATIENT USE. THE PRODUCT FAULT DID NOT CAUSE OR CONTRIBUTE TO ANY ADVERSE PATIENT HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11851250 ↗
• MalfunctionMay 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  INVESTIGATION COMPLETED WITH SUMMARY IN H 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850982 ↗
• MalfunctionMay 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  INVESTIGATION COMPLETED AND SUMMARY IN H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850583 ↗
• MalfunctionApr 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED REGARDING A LEVEL 1 HOTLINE ACCESSORY. IT WAS REPORTED THAT THE IV LINE WITH FILTER FOR HHT PATIENT WAS LEAKING AT THE FILTER SITE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11751193 ↗
• MalfunctionApr 30, 2021Break; Break

  INFORMATION WAS RECEIVED REGARDING A LEVEL 1 HOTLINE ACCESSORY. IT WAS REPORTED THAT BEFORE OPENING THE PACKAGE, THE CUSTOMER NOTICED THE CONNECTOR WAS BROKEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11751179 ↗
• MalfunctionApr 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  INVESTIGATION COMPLETED AND SUMMARY.

  Patient problems: Insufficient Information

  MAUDE report 11691051 ↗
• MalfunctionApr 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL FLUID WARMING ACCESSORY WHERE THE WARMING TUBE WAS CONNECTED HAD BROKEN CAUSING BLOOD TO LEAK. THERE WAS NO PATIENT INJURY AND NO REPORTED ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11689117 ↗

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-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-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-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-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-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-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-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