Use caution Medical device recall · FDA · Published May 30, 2024

Baxter Volara System SPU Circuit Kits: Handset Plug May Disconnect

Baxter Healthcare recalls Volara System Single Patient Use Circuit kits due to risk of handset plug disconnecting from ventilator adapter, potentially causing improper gas flow. Affected units have specific product codes and lot numbers listed.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2321-2024Medical device Baxter Healthcare ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625

✎ GovInfoNow plain-language explainer

Baxter Healthcare is recalling Volara System Single Patient Use Circuit kits because the handset plug might disconnect from the blue ventilator adapter. This could lead to improper ventilator gas flow, which is critical for patient safety during breathing treatments. Read more at govinfonow.com/recall/54975-baxter-volara-system-spu-circuit-kits-handset-plug-may-disconnect.

Source Summary by GovInfoNow · govinfonow.com/recall/54975-baxter-volara-system-spu-circuit-kits-handset-plug-may-disconnect · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2321-2024

Cite this page

“Baxter Volara System SPU Circuit Kits: Handset Plug May Disconnect.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54975-baxter-volara-system-spu-circuit-kits-handset-plug-may-disconnect. Based on FDA recall #Z-2321-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2321-2024%22&limit=1).

The FDA announced on May 30, 2024, that Baxter Healthcare Corporation is recalling Volara System Single Patient Use (SPU) Circuit kits due to the potential for the handset plug to disconnect from the nebulizer port. This defect may disrupt proper ventilator gas flow.

How to tell if you have it

Brand: Baxter Healthcare
Product: Volara System SPU Circuit 5kit for Volara and SPU Circuit kit for Volara
Product Codes: M08473/M08474
Lot numbers: 2171WA, 2237WA, 2238WA, 2241WA, 2242WA, 2243WA, 2244WA, 2249WA, 2250WA, 2251WA, 2285WA, 2286WA, 2290WA, 2297WA, 2298WA, 2299WA, 2307WA, 2308WA, 2311WA, 2332WA, 2333WA, 2341WA, 2342WA, 2349WA, 2355WA, 2356WA, 2357WA, 2363WA, 2364WA, 3019WA, 3061WA, 3067WA, 3068WA, 3069WA, 3072WA, 3073WA, 3074WA, 3080WA, 3081WA, 3094WA, 3095WA, 3096WA, 3100WA, 3101WA, 3102WA, 3103WA, 3109WA, 3110WA, 3111WA, 3123WA, 3124WA, 3152WA, 3156WA, 3157WA, 3158WA, 3213WA, 3214WA, 3215WA, 3219WA, 3240WA, 3241WA, 3268WA, 3270WA, 3271WA, 3272WA, 3297WA, 3298WA, 3299WA, 3300WA, 3303WA, 3304WA, 3305WA, 3306WA, 3310WA, 3311WA, 3313WA, 3326WA, 3327WA, 3328WA, 3331WA
Units affected: 58,220

The hazard

The recall addresses the potential for 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.

Context

GovInfoNow's records show Baxter Healthcare Corporation has 187 other recalls on record since September 2, 2015. Other recent recalls of similar products include GE Healthcare Carestation Anesthesia System Power Board Recall (November 14, 2025), ResMed Astral Ventilators Recall (June 25, 2026), and Medical Action Industries Pack Cath BHH (March 17, 2026).

How to tell if you have this one

Check for product codes starting with M08473/M08474 or lot numbers listed in the recall notice. The Volara System Single Patient Use Circuit kits are used for intermittent positive pressure breathing devices.

Brand
Baxter Healthcare
Category
Medical device

FDA recall event · 2 products

All 2 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
Nationwide distribution. International distribution to Canada, France, and Germany.

Recall number	Product, codes & lots	Quantity
Z-2321-2024	Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.; Product Codes: M08473/M08474; Lot numbers: 2171WA, 2237WA, 2238WA, 2241WA, 2242WA, 2243WA, 2244WA, 2249WA, 2250WA, 2251WA, 2285WA, 2286WA, 2290WA, 2297WA, 2298WA, 2299WA, 2307WA, 2308WA, 2311WA, 2332WA, 2333WA, 2341WA, 2342WA, 2349WA, 2355WA, 2356WA, 2357WA, 2363WA, 2364WA, 3019WA, 3061WA, 3067WA, 3068WA, 3069WA, 3072WA, 3073WA, 3074WA, 3080WA, 3081WA, 3094WA, 3095WA, 3096WA, 3100WA, 3101WA, 3102WA, 3103WA, 3109WA, 3110WA, 3111WA, 3123WA, 3124WA, 3152WA, 3156WA, 3157WA, 3158WA, 3213WA, 3214WA, 3215WA, 3219WA, 3240WA, 3241WA, 3268WA, 3270WA, 3271WA, 3272WA, 3297WA, 3298WA, 3299WA, 3300WA, 3303WA, 3304WA, 3305WA, 3306WA, 3310WA, 3311WA, 3313WA, 3326WA, 3327WA, 3328WA, 3331WA.	58,220 units
Z-2322-2024	Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.; Product Code: M07937; Lot numbers: 4210495, 4325617.	350 units

Based on the official FDA remedy

What to do — step by step

Check Product Codes
Look for product codes M08473 or M08474 on the device packaging or label.
Contact Baxter Healthcare
Reach out to Baxter Healthcare for further assistance with the recall.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide distribution. International distribution to Canada, France, and Germany.” 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 55 days after the firm started it.

May 30, 2024Firm started the recall
Jul 17, 2024FDA classified it Class I
Jul 24, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Other Baxter Healthcare recalls

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/54975-baxter-volara-system-spu-circuit-kits-handset-plug-may-disconnect">Baxter Volara System SPU Circuit Kits: Handset Plug May Disconnect (GovInfoNow)</a>

Where this comes from

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-2321-2024 (May 30, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2321-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.