Baxter Healthcare Corporation

MedWatcher tracks the reviewed device family Baxter SIGMA Spectrum Infusion System under the canonical manufacturer identity Baxter Healthcare Corporation. The recall records on this page are limited to 5 owner-approved FDA recall actions.

What MedWatcher tracks

This page covers only the reviewed device families and FDA recall actions shown below. It is not a complete product catalogue, and a recall does not necessarily affect every unit or configuration in a device family.

Reviewed device families: 1
Matched recall actions: 12
Source records last checked: Oct 8, 2026

Manufacturer identity and source matching

The manufacturer and device-family relationships come from the reviewed canonical-device inventory. Recall coverage is limited to the exact candidate IDs approved and published in the FUS-265 cohort; complete regulator payloads remain in the private source ledger.

Source databases can use a legal name, brand, division, or shortened name. MedWatcher retains the form used as evidence rather than treating every similar name as the same manufacturer.

Baxter Healthcare CorporationSource-name variantOwner-approved openFDA recall-match cohort (FUS-265)Evidence source (opens in a new tab)
Baxter Healthcare CorporationSource-name variantReviewed openFDA recalling-firm identity — FUS-265Evidence source (opens in a new tab)

Sources used for this page

U.S. Food and Drug AdministrationFDA medical device recall recordsLast checked Aug 16, 2026 openFDAMedical device recall bulk dataLast checked Aug 16, 2026

Page reviewed Aug 17, 2026 by fusiondesigner@gmail.com · Next review by Nov 17, 2026.

Infusion pumps

View category

Baxter SIGMA Spectrum Infusion System

Baxter Healthcare Corporation · Infusion pumps

Active recall record

Last checked Oct 8, 2026

Recent recall records

Class II recallOngoing

Infusion Pump recall — FDA event 98306

Pumps were released without full testing being performed, including occlusion alarm testing.

FDA · FDA event 98306Posted Feb 13, 2026

Class II recallOngoing

Baxter SIGMA Spectrum Infusion System recall — FDA event 98167

Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature…

FDA · FDA event 98167Posted Jan 16, 2026Baxter SIGMA Spectrum Infusion System

Class I recallOngoing

Novum IQ Syringe Pump recall — FDA event 97296

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement…

FDA · FDA event 97296Posted Aug 29, 2025

Class I recallOngoing

Baxter Novum IQ Large Volume Pump recall — FDA event 97164

Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level…

FDA · FDA event 97164Posted Aug 14, 2025

Class I recallOngoing

Baxter SIGMA Spectrum Infusion Pump V6 and V8 recall — FDA event 97072

Certain Spectrum infusion pumps may have an incorrect version of software.

FDA · FDA event 97072Posted Jul 17, 2025Baxter SIGMA Spectrum Infusion System

Class I recallOngoing

Baxter Novum IQ LVP INFUSION SYSTEM recall — FDA event 96721

There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.

FDA · FDA event 96721Posted May 20, 2025

Class I recallOngoing

Welch Allyn Life2000 Compressor recall — FDA event 96611

A cybersecurity vulnerability was discovered through internal testing.

FDA · FDA event 96611Posted May 9, 2025

Class I recallOngoing

Baxter Sigma Spectrum Infusion System (V6 Platform) recall — FDA event 96289

There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

FDA · FDA event 96289Posted Mar 6, 2025

Class I recallOngoing

Welch Allyn, Inc recall — FDA event 95842

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

FDA · FDA event 95842Posted Jan 16, 2025

Class II recallOngoing

Baxter SIGMA Spectrum Infusion System recall — FDA event 95848

Devices were identified as released after repair without full testing being performed, which includes flow testing.

FDA · FDA event 95848Posted Dec 27, 2024Baxter SIGMA Spectrum Infusion System

Class II recallOngoing

Baxter SIGMA Spectrum Infusion System recall — FDA event 94988

The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the…

FDA · FDA event 94988Posted Aug 16, 2024Baxter SIGMA Spectrum Infusion System

Class II recallOngoing

Baxter SIGMA Spectrum Infusion System recall — FDA event 94959

Improperly performed testing prior to release

FDA · FDA event 94959Posted Aug 7, 2024Baxter SIGMA Spectrum Infusion System

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Recent recall records

Class II recallOngoing

Infusion Pump recall — FDA event 98306

Pumps were released without full testing being performed, including occlusion alarm testing.

FDA · FDA event 98306Posted Feb 13, 2026

Class II recallOngoing

Baxter SIGMA Spectrum Infusion System recall — FDA event 98167

FDA · FDA event 98167Posted Jan 16, 2026Baxter SIGMA Spectrum Infusion System

Class I recallOngoing

Novum IQ Syringe Pump recall — FDA event 97296

FDA · FDA event 97296Posted Aug 29, 2025

Class I recallOngoing

Baxter Novum IQ Large Volume Pump recall — FDA event 97164

FDA · FDA event 97164Posted Aug 14, 2025

Class I recallOngoing

Baxter SIGMA Spectrum Infusion Pump V6 and V8 recall — FDA event 97072

Certain Spectrum infusion pumps may have an incorrect version of software.

FDA · FDA event 97072Posted Jul 17, 2025Baxter SIGMA Spectrum Infusion System

Class I recallOngoing

Baxter Novum IQ LVP INFUSION SYSTEM recall — FDA event 96721

There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.

FDA · FDA event 96721Posted May 20, 2025

Class I recallOngoing

Welch Allyn Life2000 Compressor recall — FDA event 96611

A cybersecurity vulnerability was discovered through internal testing.

FDA · FDA event 96611Posted May 9, 2025

Class I recallOngoing

Baxter Sigma Spectrum Infusion System (V6 Platform) recall — FDA event 96289

There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

FDA · FDA event 96289Posted Mar 6, 2025

Class I recallOngoing

Welch Allyn, Inc recall — FDA event 95842

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

FDA · FDA event 95842Posted Jan 16, 2025

Class II recallOngoing

Baxter SIGMA Spectrum Infusion System recall — FDA event 95848

Devices were identified as released after repair without full testing being performed, which includes flow testing.

FDA · FDA event 95848Posted Dec 27, 2024Baxter SIGMA Spectrum Infusion System

Class II recallOngoing

Baxter SIGMA Spectrum Infusion System recall — FDA event 94988

FDA · FDA event 94988Posted Aug 16, 2024Baxter SIGMA Spectrum Infusion System

Class II recallOngoing

Baxter SIGMA Spectrum Infusion System recall — FDA event 94959

Improperly performed testing prior to release

FDA · FDA event 94959Posted Aug 7, 2024Baxter SIGMA Spectrum Infusion System

Baxter Healthcare Corporation

Follow Baxter Healthcare Corporation

What MedWatcher tracks

Manufacturer identity and source matching

Sources used for this page

Infusion pumps

Baxter SIGMA Spectrum Infusion System

Recent recall records

Infusion Pump recall — FDA event 98306

Baxter SIGMA Spectrum Infusion System recall — FDA event 98167

Novum IQ Syringe Pump recall — FDA event 97296

Baxter Novum IQ Large Volume Pump recall — FDA event 97164

Baxter SIGMA Spectrum Infusion Pump V6 and V8 recall — FDA event 97072

Baxter Novum IQ LVP INFUSION SYSTEM recall — FDA event 96721

Welch Allyn Life2000 Compressor recall — FDA event 96611

Baxter Sigma Spectrum Infusion System (V6 Platform) recall — FDA event 96289

Welch Allyn, Inc recall — FDA event 95842

Baxter SIGMA Spectrum Infusion System recall — FDA event 95848

Baxter SIGMA Spectrum Infusion System recall — FDA event 94988

Baxter SIGMA Spectrum Infusion System recall — FDA event 94959

Baxter Healthcare Corporation

Follow Baxter Healthcare Corporation

What MedWatcher tracks

Manufacturer identity and source matching

Sources used for this page

Infusion pumps

Baxter SIGMA Spectrum Infusion System

Recent recall records

Infusion Pump recall — FDA event 98306

Baxter SIGMA Spectrum Infusion System recall — FDA event 98167

Novum IQ Syringe Pump recall — FDA event 97296

Baxter Novum IQ Large Volume Pump recall — FDA event 97164

Baxter SIGMA Spectrum Infusion Pump V6 and V8 recall — FDA event 97072

Baxter Novum IQ LVP INFUSION SYSTEM recall — FDA event 96721

Welch Allyn Life2000 Compressor recall — FDA event 96611

Baxter Sigma Spectrum Infusion System (V6 Platform) recall — FDA event 96289

Welch Allyn, Inc recall — FDA event 95842

Baxter SIGMA Spectrum Infusion System recall — FDA event 95848

Baxter SIGMA Spectrum Infusion System recall — FDA event 94988

Baxter SIGMA Spectrum Infusion System recall — FDA event 94959