Device recall: Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara…

Class I FDA enforcement event 98458. Recall start date: 18 Feb 2026. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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…

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Baxter Healthcare Corporation started this device recall on 18 Feb 2026. The firm address in the FDA record is in Deerfield, IL. FDA put the recall in Class I. FDA event 98458 has 1 product record. The first FDA enforcement report date is 8 Apr 2026. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Florida

Recalling firm

Baxter Healthcare Corporation, Deerfield, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 98458: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1637-2026	Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.	19 units	Class I	Ongoing	8 Apr 2026

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2026: 572
Share of these events in Class I: 12%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 193

Other events of the firm

Other FDA enforcement events of Baxter Healthcare Corporation
Initiated	Product (first record)	Type	Class	Records
17 Aug 2026	0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corpora	Drug	Class I	1
17 Aug 2026	Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, N	Drug	Class I	1
11 Aug 2026	Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS	Device	Class II	2
6 Aug 2026	Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Non	Drug	Class II	17
24 Jul 2026	Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container	Drug	Class I	1
30 Jun 2026	Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets	Device	Class I	1
21 May 2026	Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expa	Device	Class I	4
22 Apr 2026	Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing	Device	Class II	1
21 Apr 2026	Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper B	Device	Class II	1
18 Feb 2026	Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software	Device	Class II	1

Baxter Healthcare Corporation: all 193 events

Official channels

FDA enforcement report Z-1637-2026The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 98458. https://recallregister.com/fda/i/98458/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Florida
What quantity of product is in FDA event 98458?: The FDA record gives this quantity: 19 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2026 have the same class?: 12% of the 572 device events that started in 2026 are in Class I.