Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

© 2026 Go Backs. All rights reserved.

Critical RiskFDA Device
Medical Devices

Baxter Healthcare Corporation: Volara System Breathing Circuits Recalled for Disconnection Risk

Agency Publication Date: July 17, 2024
Share:
Sign in to monitor this recall

Summary

Baxter Healthcare is recalling approximately 58,570 Volara System circuit kits and blue ventilator adapter modules. The handset plug on these devices may accidentally disconnect from the nebulizer port, which is a critical component required to ensure proper ventilator gas flow and device operation. If the plug disconnects during use, it could interrupt the delivery of respiratory therapy to the patient. These devices were distributed across the United States and internationally to Canada, France, and Germany.

Risk

The disconnection of the handset plug from the ventilator adapter can lead to a loss of ventilator gas flow. This failure could result in patients receiving inadequate respiratory support, potentially leading to serious health complications or respiratory distress.

What You Should Do

  1. Identify your device by checking for Volara System Single Patient Use (SPU) Circuits with product codes M08473 or M08474, or Blue Ventilator Adapter Modules with product code M07937.
  2. For SPU Circuits (M08473/M08474), check for the following affected 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, and 3331WA.
  3. For Blue Ventilator Adapter Modules (M07937), check for lot numbers 4210495 and 4325617.
  4. Contact your healthcare provider or Baxter Healthcare Corporation immediately for instructions on how to handle affected units and to ensure patient safety.
  5. Consult the manufacturer's notification letter for technical guidance on ensuring the handset plug remains securely connected to the nebulizer port.
  6. Contact the FDA at 1-888-INFO-FDA (1-888-463-6332) if you have further questions regarding medical device recalls.

Your Remedy Options

📋Other Action

Manufacturer interaction and healthcare provider guidance.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Volara System Single Patient Use (SPU) Circuit 5kit for Volara
Model / REF:
M08473
M08474
Lot Numbers (80):
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
Product: Volara System Blue Ventilator Adapter Module
Model / REF:
M07937
Lot Numbers:
4210495
4325617

Product Images

“Volara system single-patient use circuit and blue ventilator adapter with disconnected handset plug”

“Volara system single-patient use circuit and blue ventilator adapter with disconnected handset plug”

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94713
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Hospitals; Medical clinics; Authorized medical device distributors
Manufactured In: United States
Units Affected: 2 products (58,220 units; 350 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.