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Ventec Life Systems, Inc. FDA Recalls
8 recalls on file across devices, 3 of them Class I and 8 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated ConserverClass IIJul 28, 2026Labeling; Oxygen Cylinders do not contain required medical g |
| HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post ValveClass IIJul 28, 2026Labeling; Oxygen Cylinders do not contain required medical g |
| REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post ValveClass IIJul 28, 2026Labeling; Oxygen Cylinders do not contain required medical g |
| VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001Class IIMay 8, 2026Respiratory system intended to provide continuous/intermitte |
| VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000Class IMar 25, 2026Respiratory system intended to provide continuous/intermitte |
| VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF:Class IFeb 3, 2025Multi-Function Ventilators were serviced using incorrect par |
| VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). UsedClass IJan 9, 2024The bonded spiral wrap may detach before or during ventilati |
| Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-00Class IIMay 10, 2021Due to a component failure, ventilators may unexpectedly shu |