FDA Medical devices recall ·
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2550-2026
- Date
- (initiated May 21, 2026)
- Company / brand
- Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 16187 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: 00887761981492; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2550-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.