ICU Medical Recalls Diana Automated Compounding System Due to Accuracy Issues
ICU Medical is recalling 3 units of the Diana Automated Compounding System because compounded volumes under 5ml may not meet accuracy specifications.
What this means for you
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 involves a medical device with a functional defect (inaccurate dosing) that poses a risk of harm to patients, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
ICU Medical, Inc. is recalling 3 units of the Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223. The Diana is an automated compounding device used by pharmacists to prepare solutions for patient infusion.
The recall was initiated after ICU Medical received a report that the device did not meet accuracy specifications when mixing volumes under 5ml. The affected units were distributed nationwide in the United States and in various countries worldwide.
Healthcare facilities and consumers should stop using the affected devices and contact ICU Medical for further instructions. The recall covers all serial numbers of the specific item number listed.
The recalled product
- Product
- Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 3
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 Serial Numbers
Distribution
Part of a larger recall action
This product is one of 6 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
FDA (Devices) · 2026-07-22
- SevereICU Medical Plum Solo Precision IV Pump May Deliver Excess Medication
FDA (Devices) · 2026-07-22
- HighPlum Duo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Solo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
Same hazard · inaccurate dosing
See all →- HighPresource Neurological Surgical Kits Recalled for Syringe Design Defect
FDA (Devices) · 2024-07-17
- HighCardinal Health Cardiac Catheterization Kits Recalled for Potential Syringe Design Defect
FDA (Devices) · 2024-07-17
- HighPresource surgical kits recalled for syringe design defect risk
FDA (Devices) · 2024-07-17
- HighMedline Luer Slip Syringes Recalled for Inaccurate Volume Delivery
FDA (Devices) · 2024-06-12
- HighB Braun APEX Compounding System Control Panel Module Recalled for Accuracy Issues
FDA (Devices) · 2020-12-30