Baxter Healthcare recall: Volara, HC, Na a
Baxter Healthcare Corporation is recalling Volara, HC, Na a – 2. The U.S. Food and Drug Administration published the recall on September 30, 2026; it began on August 3, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Volara, HC, Na a |
| Brand | Baxter Healthcare |
| Company | Baxter Healthcare Corporation |
| Type | Medical devices |
| Classification | Class II |
| Recall date | August 3, 2026 |
| Published by FDA | September 30, 2026 |
| Quantity | 2 |
| Recall ID | 99681 |
Recalled products
- 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
- FDA recall number
- Z-3257-2026
- Codes, lots and dates
- Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853
- Quantity
- 2
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99681
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Deerfield, IL, United States
Why it was recalled
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide distribution in the states of Colorado and Florida.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99681, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Baxter Healthcare recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Sep 30, 2026 |  Baxter Healthcare recall: Pro+ MRS Surface for Versacare and 2 more productsMedical devices · 169 units; 824 units; 6 units | There is an error in the product description on the Unique Device Identification (UDI) lab… Serious | FDA Class II |
| Sep 16, 2026 |  Baxter Healthcare recall: Dextrose InjectionDrugs · 606 bags | Presence of Particulate Matter: particulate matter identified as stainless steel particles… Most serious | FDA Class I |
| Sep 9, 2026 | Baxter Healthcare recall: 0.9% Sodium Chloride Injection USPDrugs · 145,464 500mL bags | Presence of particulate matter: Particulates identified as fiberglass Most serious | FDA Class I |
| Sep 9, 2026 | Baxter Healthcare recall: Baxter Novum IQ Syringe PumpMedical devices · 14601 units; 4 units | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a s… Serious | FDA Class II |
| Sep 9, 2026 | Baxter Healthcare recall: Vancomycin Injection and 10 more productsDrugs · N/A | manufacturing-practice violations Serious | FDA Class II |
| Aug 19, 2026 | Baxter Healthcare recall: Baxter Duo-Vent Solution Set and Male Luer Lock AdapterMedical devices · 24528 units | Baxter received customer reports of air bubbles in the drip chamber and tubing when a pres… Most serious | FDA Class I |
| Aug 19, 2026 | Baxter Healthcare recall: Cefazolin in DextroseDrugs · 19,032 bags | Presence of Particulate Matter Most serious | FDA Class I |
All 8 Baxter Healthcare recalls →
About this recall
Is Baxter Healthcare Volara, HC, Na a recalled?
Yes. Baxter Healthcare Corporation recalled it on August 3, 2026; FDA published it September 30, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
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.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.