Class I recallOngoing

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

FDA · FDA event 97072 · Posted Jul 17, 2025

Published Jul 17, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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

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

An URGENT MEDICAL DEVICE RECALL notification letter dated 6/20/25 was sent to customers.
Actions to be Taken by Customers 1. Immediately locate Spectrum pumps with the affected serial numbers and remove them from service. The product code and serial number can be found on the bottom of the infusion pump. 2. Check and record the software version installed on the pump. The software on a V6 pump should begin with the number 6 and the software on a V8 pump should begin with the number 8. The software version is located on the startup screen upon powering up the pump as pictured on the next page. Additionally, the software version is indicated in the pump menu which can be accessed by following the steps. For V6: From the Pump Information screen, press the sw info soft key to display the software version screen. For V8: From the Select Care Area screen, press the options menu soft key. Select User Options and press OK. Select View Information and press OK. Select Pump Information and press OK to display the Pump Info screen. 3. Contact Baxter to confirm the software version on the affected pumps and to schedule service if required. Baxter Global Technical Services can be reached at 800-843-7867 (select option 1, then option 2), Monday through Friday, between 7:00 am and 7:00 pm Eastern Time. 4. If you received this communication directly from Baxter, acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 5. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them

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 97072
Model	Description	Lot / serial range	Manufactured	Status
Z-2095-2025	Z-2095-2025	UDI-DI: 00085412091570; Serial Numbers: 765100 , 772744 , 789742 , 841197 , 867753 , 920606 , 1024015 770164 788724 , 793079 , 842498 , 918342 , 962810 , 1027523	Not provided in the normalized record	Ongoing
Z-2096-2025	Z-2096-2025	UDI-DI: 00085412498683; Serial Numbers: 2006307 , 2052091 , 2093765 , 2095360 , 2104302 , 2119236 , 2141815 , 2025925 , 2067699 , 2094483 , 2095541 , 2105238 , 2119436 , 2143406 , 2034297 , 2074097 , 2094580 , 2096351 , 2105769 , 2135482 , 2143684 , 2051591 , 2090658 , 2095202 , 2096856 , 2118940 , 2137976 , 2156201	Not provided in the normalized record	Ongoing

Distribution: US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Jun 20, 2025
Recall initiated
Date recorded by the FDA.
Jul 17, 2025
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: 97072
Published: Jul 17, 2025
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

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

FDA · FDA event 97072 · Posted Jul 17, 2025

Published Jul 17, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

Products affected by FDA event 97072
Model	Description	Lot / serial range	Manufactured	Status
Z-2095-2025	Z-2095-2025	UDI-DI: 00085412091570; Serial Numbers: 765100 , 772744 , 789742 , 841197 , 867753 , 920606 , 1024015 770164 788724 , 793079 , 842498 , 918342 , 962810 , 1027523	Not provided in the normalized record	Ongoing
Z-2096-2025	Z-2096-2025	UDI-DI: 00085412498683; Serial Numbers: 2006307 , 2052091 , 2093765 , 2095360 , 2104302 , 2119236 , 2141815 , 2025925 , 2067699 , 2094483 , 2095541 , 2105238 , 2119436 , 2143406 , 2034297 , 2074097 , 2094580 , 2096351 , 2105769 , 2135482 , 2143684 , 2051591 , 2090658 , 2095202 , 2096856 , 2118940 , 2137976 , 2156201	Not provided in the normalized record	Ongoing

Distribution

US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.

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 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

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

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 Pump V6 and V8 recall — FDA event 97072

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