Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported July 24, 2024
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flo…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Baxter Healthcare Corporation recalled Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (S… - a critical-severity action.
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (S… was recalled by Baxter Healthcare Corporation in July 24, 2024. Reason: Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The hand…. Check the official notice for the remedy. Verify recall #Z-2321-2024 with the FDA Devices before acting.
The recall
Baxter Healthcare Corporation issued this critical-severity FDA Devices recall-Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The hand….
- Critical
- severity level
- 58K units
- affected scope
- Class I
- classification
- July 24, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2321-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2321-2024) was formally reported on July 24, 2024, with the manufacturer initiating the action on May 30, 2024. It is classified under Critical severity (Class I), with a current status of Ongoing. Baxter Healthcare Corporation is listed as the recalling firm, operating out of Deerfield, IL. Federal records list the affected scope as 58,220 units.
The documented reason for this recall is: Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow. Distribution data in the federal record shows the product reached: Nationwide distribution. International distribution to Canada, France, and Germany.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
58,220 units
Related Recalls
6
3 from same agency
Product description
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
Reason for recall
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-2321-2024 |
| Date reported | July 24, 2024 |
| Date initiated | May 30, 2024 |
| Recalling firm | Baxter Healthcare Corporation |
| Firm location | Deerfield, IL |
| Affected scope | 58,220 units |
| Distribution | Nationwide distribution. International distribution to Canada, France, and Germany. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2321-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.. Recalled by Baxter Healthcare Corporation. Units affected: 58,220 units.
Why was this product recalled? ▼
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2024. Severity: Critical. Recall number: Z-2321-2024.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution. International distribution to Canada, France, and Germany..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2321-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 24, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.