CLASS II ONGOING Device recall · Reported 30 Oct 2024 · FDA Enforcement Report
Baxter Operating Table TruSystem 7000 U14 (MBW), Product recalled
Baxter Healthcare is recalling Baxter Operating Table TruSystem 7000 U14 (MBW), Product. The recall was initiated on 19 Sep 2024 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-0217-2025
- FDA event ID
- 95409
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Sep 2024
- FDA classified
- 24 Oct 2024
- Reported
- 30 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 19 Sep 2024 | Recall initiated by company | |
| 24 Oct 2024 | Classified by FDA | +35 days |
| 30 Oct 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Product as listed by the FDA
Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
Where it was distributed
Worldwide distribution.
Questions about this recall
Is Baxter Operating Table TruSystem 7000 U14 (MBW), Product recalled?
Yes. Baxter Healthcare recalled Baxter Operating Table TruSystem 7000 U14 (MBW), Product on 19 Sep 2024. The recall is Class II and its status is Ongoing. Recall number Z-0217-2025.
Why was it recalled?
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Which lots are affected?
UDI/DI 00887761968653, All Serial Numbers
Where was it sold?
Worldwide 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.
More recalls from Baxter Healthcare
All 564| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS I | 9% Sodium Chloride Injection USP, Viaflex recalled by Baxter HealthcareSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Drug | CLASS II | Clindamycin Phosphate in 9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |