Level 1 L-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 385 adverse event reports that list this exact device (DI 30695085407007), received between Aug 8, 2018 and Sep 22, 2026 — classified as 385 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (179 reports).

1 FDA recall record name this device's identifier, 1 still open.

10 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.

Recalls naming this device

1. Jun 24, 2026Open, Classified

   ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.

   Z-2759-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 385 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Leak/Splash

  It was stated there was a crack at the connection, and it leaked. The event occurred during use. There was no reported patient harm/adverse event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858004 ↗
• MalfunctionJul 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD LEAKED FROM THE CONNECTION BETWEEN THE HOTLINE HEATING TUBE AND THE HOTLINE MAIN UNIT DURING PRIMING. THERE WERE NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25739115 ↗
• MalfunctionJul 2, 2026Air/Gas in Device

  IT WAS REPORTED THAT DURING THERAPY WITH LEVEL 1 LOW FLOW HOTLINE DISPOSABLE SET, AIR BUBBLES OR AIR POCKETS WERE OBSERVED DEVELOPING WITHIN THE FLUID WARMING SETS. OBSERVATION WAS ASSOCIATED WITH THE CONNECTION POINT AT THE TOP OF THE WARMING SET. THERE WAS PATIENT INVOLVEMENT WITH NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25690825 ↗
• MalfunctionJun 1, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING WAS DEFECTIVE, WITH FLUID LEAKED FROM THE DISTAL END WHEN CONNECTED TO THE PATIENT. A BOLUS OF HYDROGEN AND STERILE WATER WAS ADMINISTERED TO THE PATIENT. THERE WAS PATIENT INVOLVEMENT WITH NO REPORTED HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25355387 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS FOUND DURING INVESTIGATION OF THE RETURNED DEVICE THAT A HAIRLINE CRACK AND LEAK WAS FOUND ON THE ON THE INFUSATE LINE LUER. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM. THIS REPORT CAPTURES THE SECOND OF TWO OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24522421 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS FOUND DURING INVESTIGATION OF THE RETURNED DEVICE THAT A HAIRLINE CRACK AND LEAK WAS FOUND ON THE ON THE INFUSATE LINE LUER. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM. THIS REPORT CAPTURES THE FIRST OF TWO OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24522409 ↗
• MalfunctionJan 13, 2026Blocked Connection

  IT WAS REPORTED THAT RESISTANCE AND DIFFICULTY WITH INFUSION WERE NOTICED DURING SETUP. THE ISSUE WAS RESOLVED BY REPLACING IT WITH A NEW ONE. THE EVENT HAPPENED IN THE HOSPITAL UNDER THE SUPERVISION OF A HEALTH PROFESSIONAL. THE OUTCOME WAS RESOLVED, AND NO MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058670 ↗
• MalfunctionDec 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER PRIMING, APPROXIMATELY 30 MINUTES AFTER THE PATIENT BEGAN USING THE DEVICE FOR TRANSFUSION, BLOOD WAS FOUND TO BE LEAKING FROM THE UPSTREAM CONNECTOR THAT CONNECTS TO THE INFUSION SET. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936486 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A CRACK IN THE CONNECTOR, AND THE MEDICINE LIQUID LEAKED. THE EVENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709676 ↗
• MalfunctionAug 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE BEFORE USE, BEING CONNECTED TO THE INFUSION BAG, IT WAS CONFIRMED THAT THERE WAS BREAKAGE ON THE 2 TUBE OCCURRED WHICH LEAD TO LEAKAGE OF CIRCULATING WATER. THE EVENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841605 ↗
• MalfunctionJun 23, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A LARGE NUMBER OF SMALL BUBBLES GATHER IN THE PIPES, AND THE MIDDLE AND REAR SECTIONS BECOME LARGE SECTIONS OF AIR. THE DOCTOR STOPPED USING THE DEVICE IMMEDIATELY AFTER DISCOVERING THE PROBLEM, AND NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310426 ↗
• MalfunctionJun 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING DURING THERAPY. THE EVENT TOOK PLACE WHILE IT WAS IN USE WITH A PATIENT. THE EVENT DID NOT AFFECT PATIENT CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287236 ↗
• MalfunctionMay 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK BETWEEN TRANSFUSION LINE AND HOTLINE. THE DATE OF EVENT WAS (B)(6) 2024. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010041 ↗
• MalfunctionApr 11, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE CONNECTION TO THE DEVICE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21826372 ↗
• MalfunctionFeb 3, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE DEVICE ACTIVATED AN ALARM AND COULD NOT BE USED AFTER CONNECTING. THE EVENT OCCURRED IN EARLY (B)(6)2025 IN THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294088 ↗
• MalfunctionJan 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NURSE FOUND THAT THE JOINT WAS LEAKING AND IMMEDIATELY REPLACED THE LINE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21194208 ↗
• MalfunctionJan 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NURSE FOUND THAT THE JOINT WAS LEAKING AND IMMEDIATELY REPLACED THE LINE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191663 ↗
• MalfunctionDec 31, 2024Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT WHEN THE CIRCUIT WAS PRIMED BEFORE USE TO THE PATIENT, BLOOD PRODUCT LEAKED FROM THE INFUSION SET SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21049347 ↗
• MalfunctionNov 27, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PRIMING, THE TUBING WAS LEAKING AND COULDN'T BE USED. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799463 ↗
• MalfunctionNov 27, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT THERE WAS A CRACK IN THE HEATING TUBE BODY, AND WATER LEAKS FROM THE TUBE. THE EVENT OCCURRED DURING UNPACKING AT FACILITY. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799086 ↗
• MalfunctionSep 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE CIRCUIT WAS PRIMED AND ADMINISTERED TO THE PATIENT, IT WAS ALL CLOSED WHEN CONNECTED TO THE ADMINISTRATION ROUTE, BUT DRIPS WERE SEEN. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268890 ↗
• MalfunctionSep 17, 2024Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT AFTER THE INFUSION SET WAS UNPACKED, THE INFUSION HEATER WAS INSTALLED. THERE WAS NO LIQUID OUTFLOW SEEN AND THE PIPELINE WAS FOUND TO BE BLOCKED AFTER CHANGING THE OLD EQUIPMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20240621 ↗
• MalfunctionSep 9, 2024Crack; Crack

  IT WAS REPORTED THE OPERATOR FOUND A CRACK IN THE TUBE BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171493 ↗
• MalfunctionSep 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FLUID LEAKED WHEN TRYING TO GIVE AN INFUSION. AFTER CHECKING THE APPEARANCE, A CRACK WAS FOUND IN THE PART WHERE THE INFUSION BAG WAS CONNECTED. IT IS NOT CLEAR WHETHER IT WAS ORIGINALLY CRACKED OR WHEN IT WAS CONNECTED. NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147990 ↗
• MalfunctionAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FLUID LEAKED FROM THE INSTRUMENT CONNECTION PORT, WHEN THE OPERATOR CHECKED, THERE WAS A CRACK. IT WAS UNCLEAR IF IT CRACKED WHEN CONNECTED. THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030655 ↗

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-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-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-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-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-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