ICU Medical Recalls MedNet Medication Management Suite Software
ICU Medical Inc is recalling MedNet 6.1 and 6.21 software because it may alter piggyback medication settings without user notice.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where the software may alter medication settings without notice, but no injuries or illnesses are reported in the source text.
Plain-English summary
ICU Medical Inc is recalling the ICU Mednet(TM) Medication Management Suite 6.1 and 6.21 software. The recall involves 108 installations distributed in the United States, Canada, Australia, and the Philippines. The software is intended to facilitate networked communication between computer systems and infusion pumps, allowing healthcare professionals to configure and edit infusion programming parameters.
The recall is issued because the software may change piggyback medication entry set settings for existing defined medication entries under specific conditions. These changes include altering whether a medication may be piggybacked or whether an infusion may be interrupted by a piggyback. The software does not provide notice to the user or clinician when these settings are altered. The issues occur when specific conditions regarding medication entry names, diluent amounts, rule sets, and drug library exports and imports are met.
Healthcare facilities using the affected software should contact ICU Medical Inc for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet 6.1 c) 16037-64-03; MedNet 6.1 d) 16037-64-04; MedNet 6.21 The ICU Medical MedNet Medication Management Suite (MMS) is intended to…
- Manufacturer
- ICU Medical Inc
- Category
- Medical Device — Software
- Affected units
- 108
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All MedNet 6.1 and 6.21 installations
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · ICU Medical Inc
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Same hazard · software defect
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighICU Medical Recalls Plum 360 Infusion Systems Due to Software Malfunction
FDA (Devices) · 2019-10-30
- SevereICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
FDA (Devices) · 2026-07-22
- HighMedical Information Technology Recalls MEDITECH Microbiology Software Due to Erroneous Results
FDA (Devices) · 2014-03-26
- ModeratePlum Duo infusion pumps recalled over blocked piggyback flush programming
FDA (Devices) · 2026-01-28
- SevereHospira MedNet Software Recall for Incorrect Bolus Calculations
FDA (Devices) · 2016-09-21
- ModerateICU Medical Recalls Cogent Hemodynamic Monitoring System Due to Software Defect
FDA (Devices) · 2020-05-13