CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report

Baxter TruSystem recalled by Baxter Healthcare

Baxter Healthcare is recalling Baxter TruSystem 7500, 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

Lot, batch or date codesUID/DI 00887761968639, All serial numbers manufactured until 11/14/2024.
Quantity recalled1709 units

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-1422-2025
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

Timeline

25 Feb 2025Recall initiated by company
21 Mar 2025Classified by FDA+24 days
2 Apr 2025Published 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 TruSystem 7500, Product Code 4091000

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

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 00887761968639, 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

13 other products · FDA event 96286

This product is part of a recall event; the main page for the event is Baxter TruSystem 7500 Hybrid Plus (FC) recalled by Baxter Healthcare.

ReportedClassRecallCompanyReasonWhere
CLASS IIBaxter TruSystem 7500 Hybrid Plus (FC) recalled by Baxter HealthcareBaxter HealthcareDevice MalfunctionNationwide
CLASS IIBaxter Mobile column TruSystem recalled by Baxter HealthcareBaxter HealthcareDevice MalfunctionNationwide
CLASS IIBaxter Stationary column TruSystem recalled by Baxter HealthcareBaxter HealthcareDevice MalfunctionNationwide
CLASS IIBaxter TruSystem 7500 Hybrid (MC) recalled by Baxter HealthcareBaxter HealthcareDevice MalfunctionNationwide
CLASS IIBaxter TruSystem 7500 Hybrid (SC) recalled by Baxter HealthcareBaxter HealthcareDevice MalfunctionNationwide
CLASS IIBaxter Stationary column TruSystem recalled by Baxter HealthcareBaxter HealthcareDevice MalfunctionNationwide
CLASS IIBaxter TruSystem 7500 Hybrid MR Imris recalled by Baxter HealthcareBaxter HealthcareDevice MalfunctionNationwide
CLASS IIBaxter Operating table column TS7500 Mobius recalledBaxter HealthcareDevice MalfunctionNationwide
CLASS IIBaxter TruSystem 7500 Hybrid (FC) recalled by Baxter HealthcareBaxter HealthcareDevice MalfunctionNationwide
CLASS IIBaxter TruSystem 7500 Hybrid Plus (SC) recalled by Baxter HealthcareBaxter HealthcareDevice MalfunctionNationwide
CLASS IIBaxter Floor mounting column TruSystem recalled by Baxter HealthcareBaxter HealthcareDevice MalfunctionNationwide
CLASS IIBaxter Floor mounting column TS recalled by Baxter HealthcareBaxter HealthcareDevice MalfunctionNationwide
CLASS IIBaxter Mobile column TruSystem recalled by Baxter HealthcareBaxter HealthcareDevice MalfunctionNationwide

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All 577
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DeviceCLASS IIPRO+ 40" MRS Surface, mattress recalled by Baxter HealthcareBaxter HealthcarePackaging DefectsNationwide
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All 13,857
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