FDA Medical devices recall ·
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2095-2025
- Date
- (initiated June 20, 2025)
- Company / brand
- Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 14 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Why was it recalled?
Certain Spectrum infusion pumps may have an incorrect version of software.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00085412091570; Serial Numbers: 765100 , 772744 , 789742 , 841197 , 867753 , 920606 , 1024015 770164 788724 , 793079 , 842498 , 918342 , 962810 , 1027523
Distribution
US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
States: California Florida Illinois Kansas Michigan Mississippi New York Ohio Oklahoma Virginia
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2095-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.