Level 1 L-70NIRecalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 30695085407502), received between Feb 16, 2017 and Mar 12, 2026 — classified as 114 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (66 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 114 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE OCCURRED AT THE CHAMBER CONNECTION PART WHILE THE PRODUCT WAS IN USE WITH A PATIENT. THE EVENT TOOK PLACE IN A HOSPITAL AND WAS MANAGED BY A HEALTH PROFESSIONAL. IT WAS NOT REPORTED TO THE FDA. THERE WAS NO PATIENT WAS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581305 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION SET HAD LEAKAGE AT THE LINE. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444677 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION SET HAD LEAKAGE AT THE LINE. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444538 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION SET HAD LEAKAGE AT THE LINE. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444397 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION SET HAD LEAKAGE AT THE LINE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444187 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION SET HAD LEAKAGE AT THE LINE. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444176 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION SET HAD LEAKAGE AT THE LINE. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444146 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION SET HAD LEAKAGE AT THE LINE. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444124 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION SET HAD LEAKAGE AT THE LINE. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444110 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION SET HAD LEAKAGE AT THE LINE. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444086 ↗
• MalfunctionFeb 20, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CONNECTING PIPE CRACKED AND LEAKED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401468 ↗
• MalfunctionSep 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING PRE-USE PRIMING FOR THE PATIENT, SALINE LEAKED INTO THE MOUTH WHERE THE PATIENT'S BLOOD ENTERS. AS THE ISSUE WAS DISCOVERED DURING PRE-TESTING, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22998553 ↗
• MalfunctionJun 18, 2025Backflow; Backflow

  IT WAS REPORTED THAT THE ISSUE INVOLVED THE DISPOSABLE WARM LIQUID PIPELINE TO WARM THE INFUSION FLUID PRIOR TO ANESTHESIA. DURING USE, IT WAS OBSERVED THAT THE PATIENT'S BLOOD HAD FLOWED BACK INTO THE DISPOSABLE WARM LIQUID PIPELINE. THE INTERFACE WAS CHECKED AGAIN FOR ANY LIQUID DRIPPING, BUT RE-TIGHTENING THE CONNECTION WAS INEFFECTIVE. THERE WAS A PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287576 ↗
• MalfunctionDec 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DEVICE EXHIBITED A LEAK AT THE TWIN TUBE CONNECTOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18421376 ↗
• MalfunctionNov 30, 2023Break; Material Separation; Connection Problem; Break; Material Separation; Connection Problem

  IT WAS REPORTED THAT DUE TO DAMAGE TO THE LURE PORTION OF THE CONNECTION, IT COULD NOT BE CONNECTED TO THE ROUTE AND ITS USE WAS DISCONTINUED. NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241245 ↗
• MalfunctionNov 29, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE WATER WAS LEAKING BECAUSE THE "LINE WAS DAMAGED". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18231982 ↗
• MalfunctionNov 29, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT SALINE WAS NOT CIRCULATED AFTER INJECTION. THE LIQUID STOPS AT THE MIDDLE OF THE LINE. NO MEDICAL INTERVENTION OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18231980 ↗
• MalfunctionNov 1, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT WATER WAS CONSTANTLY LEAKING DURING PRIMING. CHECKED TO CONFIRM THAT THE CONNECTION PART WAS BROKEN. NO PATIENT INVOLVED. OUTCOME OF THE EVENT WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION WAS GIVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048490 ↗
• MalfunctionNov 1, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS LEAKAGE AT THE AIR LINE. NO PATIENT INVOLVEMENT AND NO MEDICAL INTERVENTION RECORDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048451 ↗
• MalfunctionNov 1, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE HAS DAMAGE AT THE TWIN TUBE CONNECTOR AND WATER WAS LEAKING OUT. NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS RECORDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048440 ↗
• MalfunctionOct 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PRE-TESTING, THE DEVICE HAD WATER LEAKAGE FROM PATIENT SIDE CONNECTOR. NO ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17999615 ↗
• MalfunctionOct 3, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE IN USE WITH A PATIENT, A LEAK OCCURRED DUE TO DAMAGE TO THE MAIN BODY CONNECTION. ADVERSE EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17863467 ↗
• MalfunctionOct 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DEVICE HAD CONTINUOUS WATER LEAKAGE. THIS OCCURRED DURING PRIMING BEFORE USING THE PRODUCT ON THE PATIENT. NO INJURY OR ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17856040 ↗
• MalfunctionOct 2, 2023Detachment of Device or Device Component; Incomplete or Inadequate Connection; Detachment of Device or Device Component; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE TUBE WAS NOT CONNECTED. NO INJURY OR ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17856035 ↗
• MalfunctionOct 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FLUID LEAKS FROM THE PRODUCT WHILE APPLYING THE PRODUCT TO THE PATIENT FOR SURGERY. NO INJURY OR ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17855576 ↗

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-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-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-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-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-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