Level 1Recalls & reported problems across all models

Icu Medical, Inc. · 52 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names at least one Level 1 model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports: 3,733
Deaths reported: 14
Injuries reported: 34
Recalls: 1

We found 52 models of Level 1 by Icu Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 3,733 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2017 and Sep 25, 2026 — classified as 14 deaths, 34 injuries, 3,685 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (942 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Last 36 months. The most recent month may be incomplete.

Level 1 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

Most reported Level 1 problems

Device problems

Fluid/Blood Leak942
Device Alarm System402
Leak/Splash258
Temperature Problem241
Insufficient Heating182
Break140
Crack128
Overheating of Device118

Patient problems

No Clinical Signs, Symptoms or Conditions2,648
Insufficient Information619
No Information206
No Patient Involvement202
No Consequences Or Impact To Patient155
No Known Impact Or Consequence To Patient44
Burn(s)11
Death8

Level 1 models

52 models, most reported first. Each model has its own page with its reports, recalls and device details.

Level 1 HL-90
Warmer, thermal, infusion fluid
991 reports
Level 1 8002950
Warmer, blood, non-electromagnetic radiation
10 deaths931 reports
Level 1 HL-390
Warmer, thermal, infusion fluid
634 reports
Level 1 L-70
Warmer, thermal, infusion fluid
1 recall385 reports
Level 1 DI-60HL
DEVICE, WARMING. BLOOD AND PLASMA
1 death150 reports
Level 1 DI-100
DEVICE, WARMING. BLOOD AND PLASMA
3 deaths131 reports
Level 1 L-70NI
Warmer, thermal, infusion fluid
114 reports
Level 1 D-100
DEVICE, WARMING. BLOOD AND PLASMA
85 reports
Level 1 EQ-5000
System, thermal regulating
46 reports
Level 1 DI-300
DEVICE, WARMING. BLOOD AND PLASMA
44 reports
Level 1 L-10
Warmer, thermal, infusion fluid
41 reports
Level 1 L1-CW-120V
System, thermal regulating
30 reports
Level 1 L-370
Warmer, thermal, infusion fluid
24 reports
Level 1 H-1129
Warmer, thermal, infusion fluid
19 reports
Level 1 D-300
DEVICE, WARMING. BLOOD AND PLASMA
16 reports
Level 1 HL-390-38
Warmer, thermal, infusion fluid
9 reports
Level 1 SWU-2001
System, thermal regulating
8 reports
Level 1 FC400-16
CATHETER, UROLOGICAL
8 reports
Level 1 SW5-HOSE-7
System, thermal regulating
7 reports
Level 1 D-60HL
DEVICE, WARMING. BLOOD AND PLASMA
5 reports
Level 1 HL-90-38
Warmer, thermal, infusion fluid
5 reports
Level 1 SWU-2113
System, thermal regulating
4 reports
Level 1 L-270
Warmer, thermal, infusion fluid
4 reports
Level 1 SWU-2003
System, thermal regulating
3 reports
Level 1 SWU-2009
System, thermal regulating
3 reports
Level 1 HL-390-40
Warmer, thermal, infusion fluid
3 reports
Level 1 SWU-2013
System, thermal regulating
2 reports
Level 1 ER400-9
Thermometer, electronic, clinical
2 reports
Level 1 Y-INJ
DEVICE, WARMING. BLOOD AND PLASMA
2 reports
Level 1 8002911
Warmer, blood, non-electromagnetic radiation
2 reports
Level 1 HL-90-40
Warmer, thermal, infusion fluid
2 reports
Level 1 H-1100-ES-115V
Warmer, thermal, infusion fluid
2 reports
Level 1 H-31-EN
Warmer, blood, non-electromagnetic radiation
2 reports
Level 1 SWU-2002
System, thermal regulating
1 report
Level 1 SWU-2010
System, thermal regulating
1 report
Level 1 SWU-2011
System, thermal regulating
1 report
Level 1 FC400-10
CATHETER, UROLOGICAL
1 report
Level 1 FC400-14
CATHETER, UROLOGICAL
1 report
Level 1 FC400-18
CATHETER, UROLOGICAL
1 report
Level 1 L1-Hose
System, thermal regulating
1 report
Level 1 EQ-5000 115V
System, thermal regulating
1 report
Level 1 PF-1
DEVICE, WARMING. BLOOD AND PLASMA
1 report
Level 1 IR-500
Warmer, thermal, infusion fluid
1 report
Level 1 IR-600
Warmer, thermal, infusion fluid
1 report
Level 1 SW-2003
System, thermal regulating
1 report
Level 1 STS-400
Thermometer, electronic, clinical
1 report
Level 1 ES400-18
STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS
1 report
Level 1 ER400-12
Thermometer, electronic, clinical
1 report
Level 1 MTS-40015
Thermometer, electronic, clinical
1 report
Level 1 PL-6
Warmer, thermal, infusion fluid
1 report
Level 1 EQ-5000-INT-115V
System, thermal regulating
1 report
Level 1 EQ-5000HF-EN-115V
System, thermal regulating
1 report

Recent Level 1 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

MalfunctionSep 25, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903381 ↗
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 ↗
MalfunctionAug 24, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419551 ↗
DeathJul 10, 2026Obstruction of Flow
IT WAS REPORTED THAT THE PATIENT WAS IN CARDIAC ARREST FROM A DISSECTION. THEY WERE ATTEMPTING TO GIVE MULTIPLE UNITS OF BLOOD THROUGH THE LEVEL 1 INFUSER, BUT THE TUBING KEPT KINKING AND THIS CAUSED DECREASED FLOW AND PROLONGED TIME TO GIVE BLOOD TO THE PATIENT. THEY HAD TO SUPPLEMENT THE LEVEL 1 INFUSER WITH GIVING BLOOD THROUGH A PRESSURE BAG UNTIL THEY COULD GET THE TUBING UNKINKED. THEY WERE UNABLE TO PUNCTURE BLOOD BAG WITH LEVEL 1 INFUSER TUBING IN A CRITICAL SITUATION WITH A PATIENT. IT TOOK SEVERAL TRIES BY MULTIPLE PEOPLE TO PUNCTURE THE BLOOD BAG WITH THE TUBING. THE PATIENT ULTIMATELY DID NOT SURVIVE. THERE WAS PATIENT INVOLVEMENT, AND PATIENT DEATH WAS REPORTED WHILE USING ICU PRODUCT. THE DEVICE AND PATIENT DEATH WERE NOT RELATED. MEDICAL EVALUATION: BASED ON THE AVAILABLE INFORMATION, THERE IS NO OBJECTIVE EVIDENCE CONFIRMING A DEVICE MALFUNCTION, AS NO DEVICE OR LOT WAS AVAILABLE FOR EVALUATION. ADDITIONALLY, ALTERNATIVE TRANSFUSION METHODS WERE SUCCESSFULLY EMPLOYED TO CONTINUE THERAPY. WHILE THE REPORTED DEVICE PERFORMANCE ISSUES MAY HAVE CONTRIBUTED TO PROCEDURAL DELAYS, THE PRIMARY CAUSE OF DEATH IS MOST CONSISTENT WITH THE UNDERLYING MEDICAL CONDITION. IN SUMMA
Patient problems: Cardiac Arrest
MAUDE report 25782353 ↗
MalfunctionJul 8, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25752615 ↗
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 2, 2026Collapse; No Flow
IT WAS REPORTED THAT THE ADMINISTRATION LINE DID NOT FUNCTION AS INTENDED. THE TEAM WAS ABLE TO FLUSH THE LINE WITH SODIUM CHLORIDE (NACL 0.9%); HOWEVER, NO FLOW WAS OBSERVED AT THE BRANCH CONNECTION, AND THE TUBING WAS NOTED TO BE COLLAPSED. PATIENT INVOLVEMENT IS UNKNOWN, AND NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25363018 ↗
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 ↗
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 ↗
DeathMay 21, 2026Insufficient Heating
IT WAS REPORTED THAT THE INFUSER FAILED TO HEAT THE BLOOD BEING INFUSED, RESULTING IN A DELAY IN THERAPY WHILE A SECOND UNIT WAS SET UP. THE STAFF CONTINUED TO INFUSE THE BLOOD, DUE TO MASSIVE BLOOD TRANSFUSION NEEDED. THIS WAS DURING A CODE SITUATION THEY GAINED ROSC ON THE PATIENT. LATER THE PATIENT WAS TRANSITIONED TO COMFORT CARE AND PASSED AWAY. THIS EVENT OCCURRED DURING INFUSION. BASED ON THE CURRENTLY AVAILABLE COMPLAINT NARRATIVE, A PATIENT DEATH OCCURRED IN THE SETTING OF A CODE EVENT WITH REPORTED MASSIVE BLOOD TRANSFUSION, WHERE IT WAS ALLEGED THAT THE LEVEL 1® FAST FLOW FLUID WARMER FAILED TO HEAT BLOOD DURING INFUSION, RESULTING IN A DELAY IN THERAPY WHILE A SECOND UNIT WAS SET UP; ROSC WAS REPORTEDLY ACHIEVED, THE PATIENT WAS LATER TRANSITIONED TO COMFORT CARE, AND SUBSEQUENTLY DIED. THE PATIENT¿S MEDICAL HISTORY AND KEY CLINICAL CONTEXT ARE NOT PROVIDED, INCLUDING THE UNDERLYING DIAGNOSIS AND CLINICAL CIRCUMSTANCES THAT PRECIPITATED THE CODE EVENT, THE INDICATION FOR AND MAGNITUDE OF THE MASSIVE TRANSFUSION REQUIREMENT, OBJECTIVE TEMPERATURE DATA (PATIENT CORE TEMPERATURE AND/OR DEVICE OUTLET TEMPERATURE), TRANSFUSION VOLUMES AND RATES, THE DURATION OF ANY PERIOD OF
Patient problems: Insufficient Information
MAUDE report 25246136 ↗
MalfunctionMay 18, 2026Fire
IT WAS REPORTED THAT A FIRE OCCURRED WITHIN THE DEVICE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25201227 ↗
MalfunctionMay 18, 2026Fluid/Blood Leak
IT WAS REPORTED BY RN THAT LEVEL 1 RAPID INFUSER WAS USED TO ADMINISTER WARMED BLOOD PRODUCTS RAPIDLY FOR A CAT 1 TRAUMA PATIENT. DURING SETUP OF THE EQUIPMENT THE BLOOD STARTED TO LEAK FROM THE FILTER SECTION OF THE TUBING WHICH CAUSED LEAKAGE ONTO THE FLOOR. THERE WAS PATIENT INVOLVEMENT WITH NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25201066 ↗
MalfunctionMay 11, 2026Device Markings/Labelling Problem
THE CUSTOMER RETURNED THE DEVICE STATING, ¿THE PUMP HAD BEEN LEAKING INTERNALLY¿; DURING DEVICE EVALUATION IT WAS FOUND THE SERIAL NUMBER LABEL WAS BLURRY. THERE WERE NO PATIENT INVOLVEMENT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25137065 ↗
MalfunctionMay 7, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A BLOOD LEAKAGE AT THE CONNECTION PART. THE EVENT OCCURRED IMMEDIATELY ON USE AT THE HOSPITAL. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25113692 ↗

Other Icu Medical, Inc. products

All Icu Medical, Inc. devices →

Sources and updates

Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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