Notice names this product. Ventec Life Systems’s VOCSN V+Pro package is named in FDA Class I recall Z-1942-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk Identifying details: UDI-DI (REF/UDI-DI): PRT-01198-000/00855573007914, PRT-01185-000/00855573007877 Package/Device Serial Number (package serial number may include a "P" at the end): 152884, 152885, 152886, 152887, 152888, 152889, 152890, 152891, 152892, 152893, 152895, 152896, 152897, 152898, 152899, 152900, 152901, 152902, 152903, 152904, 152908, 152909, 152910, 152911, 152912, 152913, 152914, 152915, 152916, 152917, 152918, 152919, 152986, 152987, 155236, 156507, 156512, 156515, 156516, 156517, 156524, 156532. Units affected: 42. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing…
Company / brand: Ventec Life Systems recalls
Affected product: VOCSN V+Pro package recall status
Official ID Z-1942-2026 · Official record ↗
See all Ventec Life Systems recalls →
Found something wrong or missing? Report a data error.
Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.