Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1926-2018·Announced 2018-05-30

Baxter Recalls Prismaflex 7.20 US Control Units for Firmware Update

Baxter Healthcare is recalling 231 Prismaflex 7.20 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. The hazard involves a device malfunction that renders the unit inoperable (safe state) rather than causing direct injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Baxter Healthcare Corporation is recalling 231 units of the Prismaflex 7.20 US control unit (Product Code 955542). The recall covers all lots and serial numbers of the device, which is intended for Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange (TPE) for patients weighing 20 kilograms or more.

The recall is being conducted to address a potential failure mode in the pump module electronics. This failure 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. Baxter Healthcare is installing new firmware on all affected units to prevent this malfunction from occurring.

The affected devices were distributed worldwide, including the United States (including Puerto Rico), Canada, Australia, New Zealand, and various countries in Asia, the Americas, and EMEA. No specific instructions for consumers are provided in the source text, but the recall involves the installation of new firmware by the manufacturer.

The recalled product

Product: Prismaflex 7.20 US, Product Code 955542 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
Category: Medical Device — Dialysis / Renal Replacement
Hazard: device-malfunction
inoperable-device
Affected units: 231

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 →

Same manufacturer · Baxter Healthcare Corporation

See all →

Moderate
Baxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
Moderate
Baxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
Moderate
Baxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
Moderate
Baxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
Severe
Baxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16

Same hazard · device malfunction