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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Baxter Healthcare Corporation: There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.

Agency Publication Date: May 30, 2022
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Affected Products

Product: In-Line ventilator adaptor

M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT; UDI-DI: 00887761981492. Manufacturing dates February 28, 2020 to present.

Product: In-Line ventilator adaptor

M07937 MODULE, OPTIMUS HANDSET 2; UDI-DI: 00887761984622. Manufacturing dates October 17, 2019 to present.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90061
Status: Resolved
Manufacturer: Baxter Healthcare Corporation
Manufactured In: United States
Units Affected: 2 products (259 units; 9 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.