Device recall: VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.
Class I FDA enforcement event 99835. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Ventec Life Systems, Inc. started this device recall on 17 Sep 2026. The firm address in the FDA record is in Bothell, WA. FDA put the recall in Class I. FDA event 99835 has 12 product records. The first FDA enforcement report date is 28 Oct 2026. The record gives the status Ongoing. 33 of the 697 device events that started in 2026 have more product records. The median device event of 2026 has 1 product record.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distribution US nationwide including Puerto Rico.
Recalling firm
Ventec Life Systems, Inc., Bothell, WA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0122-2027 | VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support. | 4,369 units | Class I | Ongoing | 28 Oct 2026 |
| Z-0123-2027 | VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support. | 325 units | Class I | Ongoing | 28 Oct 2026 |
| Z-0124-2027 | VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support. | 1,534 units | Class I | Ongoing | 28 Oct 2026 |
| Z-0125-2027 | VC+Pro (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support. | 606 units | Class I | Ongoing | 28 Oct 2026 |
| Z-0126-2027 | VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support. | 1,532 units | Class I | Ongoing | 28 Oct 2026 |
| Z-0127-2027 | VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support. | 100 units | Class I | Ongoing | 28 Oct 2026 |
| Z-0128-2027 | VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support. | 4,368 units | Class I | Ongoing | 28 Oct 2026 |
| Z-0129-2027 | V+Pro Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number: PRT-01185-001, Package PN: N/A; Model Number: PRT-01185-002, Package PN:N/A. used for ventilatory support. | 39,568 units | Class I | Ongoing | 28 Oct 2026 |
| Z-0130-2027 | VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support. | 930 units | Class I | Ongoing | 28 Oct 2026 |
| Z-0131-2027 | VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support. | 180 units | Class I | Ongoing | 28 Oct 2026 |
| Z-0132-2027 | V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. used for ventilatory support. | 30,120 units | Class I | Ongoing | 28 Oct 2026 |
| Z-0133-2027 | V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support. | 25,112 units | Class I | Ongoing | 28 Oct 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 697
- Share of these events in Class I
- 11%
- Product records in this event
- 12Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 28 Jul 2026 | HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve | Device | Class II | 3 |
| 8 May 2026 | VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001 | Device | Class II | 1 |
| 25 Mar 2026 | VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000 | Device | Class I | 1 |
| 3 Feb 2025 | VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: P | Device | Class I | 1 |
| 9 Jan 2024 | VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used | Device | Class I | 1 |
| 10 May 2021 | Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0122-2027The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 99835. https://recallregister.com/fda/i/99835/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 3 Nov 2026
- Newest FDA report date on the register
- 28 Oct 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distribution US nationwide including Puerto Rico.
- What quantity of product is in FDA event 99835?
- The event has 12 product records. The first record gives this quantity:
4,369 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 11% of the 697 device events that started in 2026 are in Class I.