CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report
Baxter Mobile column TruSystem 7500 U, Product recalled
Baxter Healthcare is recalling Baxter Mobile column TruSystem 7500 U, Product, distributed nationwide in the US. The recall was initiated on 25 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1413-2025
- FDA event ID
- 96286
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Feb 2025
- FDA classified
- 21 Mar 2025
- Reported
- 2 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 25 Feb 2025 | Recall initiated by company | |
| 21 Mar 2025 | Classified by FDA | +24 days |
| 2 Apr 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Baxter Mobile column TruSystem 7500 U, Product Code 1730720
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Baxter Mobile column TruSystem 7500 U, Product recalled?
Yes. Baxter Healthcare recalled Baxter Mobile column TruSystem 7500 U, Product on 25 Feb 2025. The recall is Class II and its status is Ongoing. Recall number Z-1413-2025.
Why was it recalled?
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Which lots are affected?
UID/DI 00887761974388, All serial numbers manufactured until 11/14/2024.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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