Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory
Summary
The FDA issued a Class I for Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. by Baxter Healthcare Corporation. Reason: Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a.
Details
Source
Device Recall
External ID
Z-1637-2026
Action Date
2026-04-08
Status
Ongoing
Category
device
Product Description
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Lot/Code Info: UDI/DI number 00887761984622
Quantity Affected: 19 units
Reason for Recall
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.
Distribution
Florida
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-18
Company
Deerfield, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 252 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1637-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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