Baxter Prismaflex 5.10 US Control Units Recalled for Firmware Update
Baxter Healthcare is recalling 1,256 Prismaflex 5.10 US control units to install new firmware that prevents a pump module electronics failure.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a failure mode that results in the device entering a safe state and becoming inoperable, with no reported injuries or illnesses. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm is not reported.
Plain-English summary
Baxter Healthcare Corporation is recalling 1,256 units of the Prismaflex 5.10 US control unit (Product Code 113081). The recall covers all lots and serial numbers distributed worldwide, including the United States, Puerto Rico, Canada, Australia, and numerous other countries in Asia, the Americas, and EMEA.
The recall is being conducted to install new firmware on the devices to address a potential failure mode in the pump module electronics. This failure mode may cause a "Voltage Out of Range" malfunction alarm, which forces the device into a safe state and renders it inoperable until it is serviced. The new firmware is designed to prevent this malfunction from occurring.
The Prismaflex Control Unit is intended for Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more. All treatments administered via the unit must be prescribed by a physician. Healthcare facilities should contact Baxter Healthcare to schedule the firmware installation.
The recalled product
- Product
- Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE)…
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 1,256
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 Lots and Serial Numbers
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 recalled by Baxter Healthcare Corporation 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 5 products in this recall →Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- ModerateBaxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
Same hazard · electronic failure
See all →- High
- SevereMaquet Datascope Recalls CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps
FDA (Devices) · 2018-06-06
- SevereMaquet CS 100i Intra-Aortic Balloon Pump Recalled for Fluid Ingress
FDA (Devices) · 2017-09-13
- HighStryker S3 MedSurg Bed Fowler Control Failure Recall
FDA (Devices) · 2016-08-17
Similar recalls
- HighBaxter Recalls Prismaflex Control Units Due to Software and Usage Issues
FDA (Devices) · 2018-04-11
- ModerateBaxter Recalls Prismaflex Control Units Due to Tubing Performance Variability
FDA (Devices) · 2021-03-31
- SevereBaxter Prismaflex Control Unit Recalled for Potential Therapy Interruption
FDA (Devices) · 2019-11-13
- SevereBaxter Prismaflex Control Unit Recalled for Communication Error Alarms
FDA (Devices) · 2019-11-13
- SevereBaxter Prismaflex Control Unit Software Recall for Therapy Interruption Risk
FDA (Devices) · 2019-11-13
- HighPrismaflex M Set Medical Device Recalled Due to Instruction Mistranslation
FDA (Devices) · 2022-10-19