LifeshieldRecalls & reported problems across all models

ICU Medical, Inc. · 34 models in the FDA device registry

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name at least one Lifeshield model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports: 208
Deaths reported: 0
Injuries reported: 5
Recalls: 2

We found 34 models of Lifeshield by ICU Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 208 adverse event reports in the FDA's MAUDE database, received between Dec 27, 2016 and Sep 9, 2026 — classified as 5 injuries, 203 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (75 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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.

Lifeshield 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.

May 12, 2026Class IIOpen, Classified
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
Z-3160-2026 · Root cause: Process control · names 11 of these models · Recall details · FDA record ↗
May 12, 2026Class IIOpen, Classified
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
Z-3156-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported Lifeshield problems

Device problems

Fluid/Blood Leak75
Particulates60
Contamination21
No Flow10
Free or Unrestricted Flow8
Material Separation7
Material Rupture6
Disconnection5

Patient problems

No Clinical Signs, Symptoms or Conditions180
Chemical Exposure18
No Consequences Or Impact To Patient15
Low Blood Pressure/ Hypotension3
Arrhythmia2
Blood Loss2
No Known Impact Or Consequence To Patient2
No Patient Involvement2

Lifeshield models

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

Lifeshield 1423028
Set, administration, intravascular
1 recall48 reports
Lifeshield 1266128
Set, administration, intravascular
1 recall5 reports
Lifeshield 1495188
Set, administration, intravascular
1 recall3 reports
Lifeshield 2066928
Set, administration, intravascular
1 recall1 report
Lifeshield 1266328
Set, administration, intravascular
1 recall0 reports
Lifeshield 2067128
Set, administration, intravascular
1 recall0 reports
Lifeshield 1266528
Set, administration, intravascular
1 recall0 reports
Lifeshield 1266928
Set, administration, intravascular
1 recall0 reports
Lifeshield 1272828
Set, administration, intravascular
1 recall0 reports
Lifeshield 1423528
Set, administration, intravascular
1 recall0 reports
Lifeshield 1422728
Set, administration, intravascular
1 recall0 reports
Lifeshield 1422228
Set, administration, intravascular
1 recall0 reports
Lifeshield 2066828
Set, administration, intravascular
38 reports
Lifeshield 1266228
Set, administration, intravascular
27 reports
Lifeshield 1422928
Set, administration, intravascular
26 reports
Lifeshield 1265028
Set, administration, intravascular
10 reports
Lifeshield 1266028
Set, administration, intravascular
9 reports
Lifeshield 1266428
Set, administration, intravascular
9 reports
Lifeshield 1243502
Set, administration, intravascular
7 reports
Lifeshield 0269428
Set, administration, intravascular
3 reports
Lifeshield 1235405
Set, administration, intravascular
3 reports
Lifeshield 1264828
Set, administration, intravascular
3 reports
Lifeshield 2065428
Set, administration, intravascular
3 reports
Lifeshield 1205328
Set, administration, intravascular
2 reports
Lifeshield 1267228
Set, administration, intravascular
2 reports
Lifeshield 1140228
Set, administration, intravascular
1 report
Lifeshield 1141505
Set, administration, intravascular
1 report
Lifeshield 1265728
Set, administration, intravascular
1 report
Lifeshield 2065528
Set, administration, intravascular
1 report
Lifeshield 1267828
Set, administration, intravascular
1 report
Lifeshield 1421728
Set, administration, intravascular
1 report
Lifeshield 1422128
Set, administration, intravascular
1 report
Lifeshield 1421828
Set, administration, intravascular
1 report
Lifeshield 1273465
Set, administration, intravascular
1 report

Recent Lifeshield adverse event reports

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

MalfunctionSep 9, 2026Particulates
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699650 ↗
MalfunctionAug 27, 2026Fluid/Blood Leak
A reported incident involving a Extension Set, 17 Inch, 0.2 Micron Filter, CLAVE(TM) Y-Site, Secure Lock. It was reported that an infant was receiving Total Parenteral Nutrition (TPN) through IV tubing when leakage was observed from the filter. The filter was connected to the administration set infusing the TPN solution. Upon identification of the leak, the filter was removed and replaced using sterile technique, and the TPN infusion was resumed. No blood or body fluids were present in the line. The event occurred during infusion and no injury or adverse event was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487078 ↗
MalfunctionJun 29, 2026Particulates
A REPORTED INCIDENT INVOLVING A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH HAVE BLACK DOTS NOTED IN HUNDREDS OF ICU MEDICAL IV TUBING. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25659416 ↗
MalfunctionJun 22, 2026Particulates
THE EVENT INVOLVED SECONDARY SET, SECURE LOCK, 34 INCH WHICH WAS REPORTED THAT THE HOSPITAL WAS NOTIFIED BY THE DEPARTMENT OF PUBLIC HEALTH OF CONTAMINATED IV TUBING SETS FROM THE MANUFACTURER, ICU MEDICAL. PER THE ALERT RECEIVED. THE CONTAMINATION WAS REPORTED AS SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS AND HAS BEEN REPORTED IN NUMEROUS LOTS ACROSS THREE PRODUCT TYPES FROM ICU MEDICAL. IN SOME PRODUCTS, PARTICULATE MATTER APPEARS IN THE LUMEN OR CHAMBER OF THE TUBING. THE PARTICULATE MATTER WAS APPEARED TO BE EMBEDDED IN THE PLASTIC MATERIAL BUT NOT WITHIN THE LUMEN OR CHAMBER. NO ADVERSE EVENTS HAVE BEEN LINKED TO THE PRODUCTS, AND THE BIOLOGICAL NATURE OF THE PARTICULATES REMAINS UNKNOWN. THE EVENT OCCURRED PRIOR TO PATIENT USE AND UPON INSPECTION OF THE PRODUCT. IN ADDITION TO THE BLACK SPECK IT WAS ALSO NOTED THAT THERE WAS SOME WHITE CONTAMINANTS PRESENCE IN THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT AND PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25580419 ↗
MalfunctionJun 22, 2026Crack; No Flow
A EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH WAS REPORTED THAT THE BLUE Y-SITE CLOSEST TO THE HUB WAS CRACKED AND BACK FLOWED BLOOD. THERE WERE A PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25576634 ↗
MalfunctionJun 21, 2026Contamination
AN EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING THE PRODUCT SECONDARY SET, SECURE LOCK, 34 INCH REPORTING THAT THERE WERE BLACK SPECKS IN THE DRIP CHAMBERS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25572325 ↗
MalfunctionJun 19, 2026Particulates
THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH THAT BLACK DOTS NOTED IN MEDICAL IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25566628 ↗
MalfunctionJun 19, 2026Particulates
A REPORTED INCIDENT INVOLVING A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH WITH BLACK DOTS NOTED IN IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25566061 ↗
MalfunctionJun 19, 2026Particulates
A REPORTED INCIDENT INVOLVING A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH WITH BLACK DOTS NOTED IN IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25565821 ↗
MalfunctionJun 19, 2026Particulates
THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH THAT BLACK DOTS IN MEDICAL IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25565581 ↗
MalfunctionJun 19, 2026Particulates
THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH THAT BLACK DOTS NOTED IN MEDICAL IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25564898 ↗
MalfunctionJun 19, 2026Particulates
A REPORTED INCIDENT INVOLVING A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH WITH BLACK DOTS NOTED IN IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25564533 ↗
MalfunctionJun 19, 2026Particulates
A REPORTED INCIDENT INVOLVING A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH WITH BLACK DOTS NOTED IN IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25563950 ↗
MalfunctionJun 19, 2026Particulates
A REPORTED INCIDENT INVOLVING A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH WITH BLACK DOTS NOTED IN IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25563340 ↗
MalfunctionJun 19, 2026Particulates
THE EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 3 CLAVE Y-SITES, SECURE LOCK, 100 INCH THAT BLACK DOTS NOTED IN MEDICAL IV TUBING. THERE WERE NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25562311 ↗

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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