Use cautionMedical device recall · FDA · Published May 21, 2026
Hillrom Volara System Circuit Kit: Air Leaks Risk Oxygen Drop During Therapy
Hillrom recalls Volara System circuit kits with potential air leaks causing oxygen drops. Affected units have model REF M08473 and were sold starting April 28, 2025. Stop using if leaks occur.
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Take action
Contact the company
📍Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625
✎ GovInfoNow plain-language explainer
Baxter Healthcare Corporation recalls Hillrom Volara System circuit kits that may leak air during therapy, risking low oxygen levels and ineffective medication delivery. This happens when the nebulizer cup isn't properly locked after adding medication. Read more at govinfonow.com/recall/49094-hillrom-volara-system-circuit-kit-air-leaks-risk-oxygen-drop.
“Hillrom Volara System Circuit Kit: Air Leaks Risk Oxygen Drop During Therapy.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49094-hillrom-volara-system-circuit-kit-air-leaks-risk-oxygen-drop. Based on FDA recall #Z-2550-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2550-2026%22&limit=1).
Baxter Healthcare Corporation recalled Hillrom VOLARA System P.CIRCUIT KIT AC nebulizer circuits due to air and medication leakage risks, the FDA announced on May 21, 2026. The issue may cause oxygen level drops in patients.
How to tell if you have it
Brand: Hillrom
Product: VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit)
Model/Catalog Number: REF M08473
Lot Numbers: All lot numbers distributed beginning on 4/28/2025
Units affected: 16,187
The hazard
Reports indicate air and medication leakage from the nebulizer cup during therapy, potentially leading to oxygen level drops and ineffective nebulization. The FDA stated this issue is associated with improper locking of the nebulizer cup after adding medication. No specific incidents or injuries were reported in the record.
Context
GovInfoNow's records show Baxter Healthcare Corporation has had 187 other recalls since September 2, 2015. Recent Baxter recalls include a PRO+ 40" MRS SURFACE Mattress recall on August 18, 2026, for incorrect labeling risk and a Sodium Chloride Injection recall on August 17, 2026, for fiberglass particulates risk. Other recent recalls of similar products include NOXBOX Nitric Oxide Delivery System Recall (August 19, 2026), ICU Medical CADD Yellow Medication Cassette Reservoir Recall (August 20, 2026), and Hamilton Medical Breathing Circuit Sets Risk (May 29, 2026).
How to tell if you have this one
Check for the model number REF M08473 on the circuit kit. The product was sold starting April 28, 2025, with all lot numbers from that date onward.
Brand
Hillrom
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Recall number
Product, codes & lots
Quantity
Z-2548-2026
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device; UDI: 00887761985018, Lot Numbers: All lot numbers distributed beginning on 4/28/2025
10540 units
Z-2549-2026
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device; UDI: 10887761985015; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
0
Z-2550-2026
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device; UDI: 00887761981492; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
16187 units
Z-2551-2026
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device; UDI: 10887761981499; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
13881 units
Based on the official FDA remedy
What to do — step by step
Check for Leaks
Look for air leaks around the nebulizer cup after adding medication. If leaks occur, stop using the circuit kit immediately.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2550-2026 (May 21, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2550-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.