Class II recallOngoing

Baxter SIGMA Spectrum Infusion System recall — FDA event 94959

FDA · FDA event 94959 · Posted Aug 7, 2024

Published Aug 7, 2024Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Improperly performed testing prior to release

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

The impacted customer was contacted via phone call on 6/14/2024. Baxter has asked the customer to locate the affected pump at their facility and return the device to Baxter to be serviced.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This record references Baxter SIGMA Spectrum Infusion System by Baxter Healthcare Corporation.

Products affected by FDA event 94959
Model	Description	Lot / serial range	Manufactured	Status
Z-2530-2024	Z-2530-2024	Product Code: 35700BAX2. Serial Number: 2158913.	Not provided in the normalized record	Ongoing

Distribution: US Nationwide distribution in the state of Florida.
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Jun 14, 2024
Recall initiated
Date recorded by the FDA.
Aug 7, 2024
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 94959
Published: Aug 7, 2024
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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

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 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

Loading MedWatcher information…

Baxter SIGMA Spectrum Infusion System recall — FDA event 94959

FDA · FDA event 94959 · Posted Aug 7, 2024

Published Aug 7, 2024Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

Products affected by FDA event 94959
Model	Description	Lot / serial range	Manufactured	Status
Z-2530-2024	Z-2530-2024	Product Code: 35700BAX2. Serial Number: 2158913.	Not provided in the normalized record	Ongoing

Distribution

US Nationwide distribution in the state of Florida.

Units affected

See official FDA record

Baxter SIGMA Spectrum Infusion System recall — FDA event 98167

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

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 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

Baxter SIGMA Spectrum Infusion System recall — FDA event 94959

Follow Baxter SIGMA Spectrum Infusion System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Baxter SIGMA Spectrum Infusion System recall — FDA event 94959

Follow Baxter SIGMA Spectrum Infusion System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline