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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.

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Critical RiskFDA Device
Medical Devices/Home Healthcare

Covidien: Puritan Bennett 500 Series Ventilators Recalled for Harmful Chemical Emission

Agency Publication Date: August 2, 2024
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Summary

Covidien is recalling approximately 34,642 Puritan Bennett 500 Series Ventilators, including models 520, 540, and 560. These medical devices were found to release a harmful volatile organic compound (VOC) called 2-propanol, 1,3-dichloro from internal components after extended use. While a single ventilator is safe for its 10-year service life, using multiple affected ventilators for a total of more than 14 years across a patient's treatment could pose serious health risks.

Risk

If a patient is exposed to these ventilators for a cumulative duration of more than 14 years, they may inhale 2-propanol, 1,3-dichloro, a chemical released by the ventilator's gas pathway that can cause toxic effects or respiratory harm.

What You Should Do

  1. Check your ventilator's model and reference number to see if it is part of this recall. Affected models include the Puritan Bennett 560 (REF 4096600, 4096600-01 through 06, DL4096600, DL4096600-06), Puritan Bennett 540 (REF 4097100, DL4097100, DS4097100), and Puritan Bennett 520 (REF 4098300, 4098300-01, 4098300-02, 4098300-03, 4098300-05, 4098300-06).
  2. Ensure that any single affected ventilator is only used for its labeled 10-year service life.
  3. If you are a caregiver or patient requiring long-term ventilation that spans more than 14 years of total use across multiple devices, consult with your healthcare provider immediately to discuss alternative ventilation options.
  4. Review the User Manual and Clinician's Manual addendum (PT00196729 A, dated 2024-06-11) provided by the manufacturer for updated safety instructions regarding the service life of these devices.
  5. Contact your healthcare provider or Covidien/Medtronic for further instructions and information regarding potential device replacement or service support.
  6. For additional questions, contact the FDA at 1-888-463-6332 or visit the FDA medical device recall website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Limitation of service life and updated manual instructions.

How to: Limit any single affected ventilator to a 10-year service life and ensure cumulative duration across multiple devices does not exceed 14 years. Contact your healthcare provider or the manufacturer for further instructions.

Affected Products

Product: Puritan Bennett 560 Ventilator
Model / REF:
4096600
4096600-01
4096600-02
4096600-03
4096600-04
4096600-05
4096600-06
DL4096600
DL4096600-06
UPC Codes:
10884521087798
10884521195998
10884521196001
10884521196018
10884521196025
10884521196032
10884521196377
10884521786509
10884521786516
Lot Numbers:
All serial numbers used before 2024-06-11
Date Ranges: Distributed before June 11, 2024
Product: Puritan Bennett 540 Ventilator
Model / REF:
4097100
DL4097100
DS4097100
UPC Codes:
4097100
Lot Numbers:
All serial numbers used before 2024-06-11
Date Ranges: Distributed before June 11, 2024
Product: Puritan Bennett 520 Ventilator
Model / REF:
4098300
4098300-01
4098300-02
4098300-03
4098300-05
4098300-06
UPC Codes:
10884521183636
10884521195943
10884521195967
10884521195981
10884521196384
Lot Numbers:
All serial numbers used before 2024-06-11
Date Ranges: Distributed before June 11, 2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94855
Status: Active
Manufacturer: Covidien
Sold By: Hospital supply chains; Medical device distributors; Home healthcare providers
Manufactured In: United States
Units Affected: 34,642
Distributed To: Kentucky, Ohio, Georgia, Minnesota, Indiana, Utah, Illinois, New Jersey, New York, Puerto Rico, Louisiana, Maryland, Missouri, Tennessee, Massachusetts, Maine, California, South Carolina, Arkansas, Texas, Wisconsin, Pennsylvania, Colorado, Michigan, New Mexico, Rhode Island, Virginia, District of Columbia, Vermont, North Carolina, New Hampshire, West Virginia, Nevada, Iowa

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 ยท 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.