CLASS I ONGOING Device recall · Reported 28 Oct 2026 · FDA Enforcement Report
Vocsn (Japan) recalled by Ventec Life Systems
Ventec Life Systems is recalling Vocsn (Japan), distributed nationwide in the US. The recall was initiated on 17 Sep 2026 and the FDA has classified it as Class I.
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-0127-2027
- FDA event ID
- 99835
- Recalling firm
- Ventec Life Systems, Bothell, WA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 17 Sep 2026
- FDA classified
- 20 Oct 2026
- Reported
- 28 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- CPAP & Ventilators
Timeline
| 17 Sep 2026 | Recall initiated by company | |
| 20 Oct 2026 | Classified by FDA | +33 days |
| 28 Oct 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
Where it was distributed
Distribution US nationwide including Puerto Rico.
Questions about this recall
Why was it recalled?
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
Which lots are affected?
All Serial Numbers: UDI: 00850018761130
Where was it sold?
Distribution US nationwide including Puerto Rico.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 3 Nov 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
11 other products · FDA event 99835More recalls from Ventec Life Systems
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Vocsn+Pro recalled by Ventec Life Systems | Ventec Life Systems | Packaging Defects | Nationwide |
| Device | CLASS I | VC+Pro recalled by Ventec Life Systems | Ventec Life Systems | Packaging Defects | Nationwide |
| Device | CLASS I | V*Home recalled by Ventec Life Systems | Ventec Life Systems | Packaging Defects | Nationwide |
| Device | CLASS I | V+Pro recalled by Ventec Life Systems | Ventec Life Systems | Packaging Defects | Nationwide |
| Device | CLASS I | VC Model Number: Prt-01098-000, Package PN:Prt-01125-000. used recalled | Ventec Life Systems | Packaging Defects | Nationwide |
Other CPAP & Ventilators recalls
All 568| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Vocsn+Pro recalled by Ventec Life Systems | Ventec Life Systems | Packaging Defects | Nationwide |
| Device | CLASS I | VC+Pro recalled by Ventec Life Systems | Ventec Life Systems | Packaging Defects | Nationwide |
| Device | CLASS I | V*Home recalled by Ventec Life Systems | Ventec Life Systems | Packaging Defects | Nationwide |
| Device | CLASS I | V+Pro recalled by Ventec Life Systems | Ventec Life Systems | Packaging Defects | Nationwide |
| Device | CLASS I | VC Model Number: Prt-01098-000, Package PN:Prt-01125-000. used recalled | Ventec Life Systems | Packaging Defects | Nationwide |