CLASS II ONGOING Device recall · Reported 14 Jan 2026 · FDA Enforcement Report
The Pressio 2 ICP Monitoring System recalled by Sophy
Sophysa is recalling The Pressio 2 ICP Monitoring System, distributed nationwide in the US. The recall was initiated on 17 Nov 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-1029-2026
- FDA event ID
- 98073
- Recalling firm
- Sophysa, Besancon
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Nov 2025
- FDA classified
- 8 Jan 2026
- Reported
- 14 Jan 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 17 Nov 2025 | Recall initiated by company | |
| 8 Jan 2026 | Classified by FDA | +52 days |
| 14 Jan 2026 | 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
Customer complaints of Pressio monitor rebooting.
Product as listed by the FDA
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Where it was distributed
US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
Nationwide ArizonaCaliforniaFloridaIdahoNew JerseyOklahomaOregonTexasWisconsin
Questions about this recall
Why was it recalled?
Customer complaints of Pressio monitor rebooting.
Which lots are affected?
UDI/DI 03760124132076, All monitors
Where was it sold?
US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
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.
More recalls from Sophysa
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pressio¿ Ventricular Intracranial Pressure Monitoring Kit recalled | Sophysa | Packaging Defects | Nationwide |
| Device | CLASS II | Pressio¿ Ventricular Intracranial Pressure Monitoring Kit recalled | Sophysa | Packaging Defects | Nationwide |
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| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |