Ventec recalls pediatric oxygen breathing packages with spiral wrap that may detach during use, risking leaks or occlusions that could cause serious injury or death, especially for ventilator-dependent patients.
The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural integrity, functionality and/ or performance resulting in occlusions or leaks of the breathing circuit which may cause serious injury or death. The risk of injury or death is increased for ventilator dependent patients.
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Contact the company
📍Recalling firmVentec Life Systems, Inc.22002 26th Ave Se · Bothell, WA 98021-4903
“Ventec Pediatric Oxygen Breathing Package Recall: Spiral Wrap Detachment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56369-ventec-pediatric-oxygen-breathing-package-recall-spiral-wrap-detachment-risk. Based on FDA recall #Z-1070-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1070-2024%22&limit=1).
The FDA announced on Jan. 9, 2024, that Ventec Life Systems, Inc. is recalling the VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001 due to a Class I hazard. The bonded spiral wrap may detach, causing occlusions or leaks that could result in serious injury or death.
According to the FDA, the bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment can compromise structural integrity and performance, resulting in occlusions or leaks of the breathing circuit which may cause serious injury or death. The risk is increased for ventilator-dependent patients.
Context
GovInfoNow's records show Ventec Life Systems, Inc. has had five other recalls since May 10, 2021. Other recent recalls of similar products include Baxter Blue Ventilator Adapter Module Recall (Feb. 18, 2026), Medline Breathing Circuits Recall (July 13, 2026), and Medline Hudson RCI Breathing Circuits Recall (July 13, 2026).
How to tell if you have this one
Check for the package with part number PRT-01013-000 and pouch part number PRT-00802-001. This product was sold with the VOCSN Unified Respiratory System for ventilator support.
Brand
Ventec
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using Now
Immediately stop using the recalled breathing package as it may detach and cause serious injury or death.
Where it went and when
Where it was distributed
Distributed in 8 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “U.S.: CA, CO, FL, HI, IN, MO, NC, and WA O.U.S.: Japan” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Florida, Hawaii, Indiana, Missouri, North Carolina, Washington.
Recall timeline
FDA published this recall 57 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1070-2024 (January 9, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1070-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.