Device recall: Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product…

Class II FDA enforcement event 99681. Recall start date: 3 Aug 2026. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Baxter Healthcare Corporation started this device recall on 3 Aug 2026. The firm address in the FDA record is in Deerfield, IL. FDA put the recall in Class II. FDA event 99681 has 1 product record. The first FDA enforcement report date is 30 Sep 2026. The record gives the status Ongoing. 278 of the 677 device events that started in 2026 have more product records. The median device event of 2026 has 1 product record.

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 27 Oct 2026.

Distribution

In the words of FDA.

US Nationwide distribution in the states of Colorado and 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 99681: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-3257-2026	Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No	2	Class II	Ongoing	30 Sep 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 II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2026: 677
Share of these events in Class II: 87%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 196

Other events of the firm

Other FDA enforcement events of Baxter Healthcare Corporation
Initiated	Product (first record)	Type	Class	Records
14 Sep 2026	Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Descriptio	Device	Class II	1
18 Aug 2026	PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake	Device	Class II	3
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

Baxter Healthcare Corporation: all 196 events

Official channels

FDA enforcement report Z-3257-2026The 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.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 99681. https://recallregister.com/fda/ii/99681/. Source: openFDA enforcement reports. Data through 27 Oct 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 27 Oct 2026
Newest FDA report date on the register: 21 Oct 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: US Nationwide distribution in the states of Colorado and Florida.
What quantity of product is in FDA event 99681?: The FDA record gives this quantity: 2
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2026 have the same class?: 87% of the 677 device events that started in 2026 are in Class II.