NRFitRecalls & reported problems across all models
Icu Medical, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one NRFit model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 641
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 4
We found 6 models of NRFit by Icu Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 641 adverse event reports in the FDA's MAUDE database, received between May 12, 2020 and Sep 30, 2026 — classified as 1 injury, 640 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (504 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 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
NRFit 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.
- Aug 20, 2026Open, Classified
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.
Z-3212-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- Aug 6, 2025Open, Classified
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Z-2527-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Dec 9, 2022Open, Classified
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
Z-0966-2023 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Dec 9, 2022Open, Classified
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
Z-0965-2023 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
Most reported NRFit problems
Device problems
- Fluid/Blood Leak504
- Leak/Splash74
- Insufficient Flow or Under Infusion14
- Obstruction of Flow14
- Loss of or Failure to Bond13
- Break11
- Complete Blockage7
- Device Alarm System6
Patient problems
- No Clinical Signs, Symptoms or Conditions567
- No Consequences Or Impact To Patient56
- Insufficient Information8
- No Patient Involvement6
- No Information5
- Skin Infection1
NRFit models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NRFit 21-7609-24Administrations sets with neuraxial connectors3 recalls484 reports
- NRFit 21-7600-24Administrations sets with neuraxial connectors4 recalls94 reports
- NRFit 21-7624-24Set, i.V. Fluid transfer2 recalls23 reports
- NRFit 21-7605-24Set, i.V. Fluid transfer28 reports
- NRFit 21-7608-24Administrations sets with neuraxial connectors10 reports
- NRFit 21-7664-24Set, i.V. Fluid transfer2 reports
Recent NRFit adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952533 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951532 ↗MalfunctionSep 29, 2026Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940224 ↗MalfunctionSep 25, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900934 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891435 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
It was reported that fluid leakage was observed from the base of the cassette connection port during priming. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886998 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874113 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874051 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
It was reported that the NRFit CADD Medication Cassette leaking solution. The event occurred during priming. There was no patient involvement and no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867373 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848307 ↗MalfunctionSep 17, 2026Fluid/Blood Leak
It was reported that fluid leakage was confirmed near the connection point between the medication cassette and the extension set. There was patient involvement; however, no additional adverse consequences were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803901 ↗MalfunctionSep 17, 2026Fluid/Blood Leak
It was reported that during medication filling, the leakage was observed on the NRFit medication cassette connection between the tube and connector. This issue poses a potential risk of leak and creates a hazardous situation for the patient, including possible exposure to the drug. There was a patient involvement; however, no harm/adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802815 ↗MalfunctionSep 16, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795383 ↗MalfunctionSep 15, 2026Leak/Splash
It was stated there was a leak from the connector and tube connection. The event occurred during priming.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777200 ↗MalfunctionSep 15, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777105 ↗
Other Icu Medical, Inc. products
- CADD123 models · 53,012 reports · 21 recalls
- Medfusion16 models · 13,114 reports · 5 recalls
- Bivona469 models · 2,811 reports · 29 recalls
- Level 152 models · 3,733 reports · 1 recall
- Portex409 models · 3,479 reports · 5 recalls
- Cleo6 models · 2,782 reports
- Pneupac23 models · 1,972 reports
- Medex98 models · 774 reports · 23 recalls
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.
How reports and recalls are matched · Editorial policy · Report an error on this page