Lower risk Medical device recall · FDA · Published June 24, 2024

Puritan Bennett 560 Ventilators: Long-term use may cause health risks from VOCs

Puritan Bennett 560 ventilators used for more than 14 years of cumulative service may release harmful VOCs. Owners should check if their device was sold before June 2024 with specific serial numbers.

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

🇺🇸 FDA recall #Z-2446-2024Medical device Puritan Bennett ›

Lower-risk recall

Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator over time, the use of these devices for more than 14 years of cumulative duration may pose harm to health due to a volatile organic compound (VOC), 2-propanol, 1,3-dichloro released from some components in the ventilator gas pathway

Take action

Contact the company

Recalling firmCovidien2101 Faraday Ave · Carlsbad, CA 92008-7205

✎ GovInfoNow plain-language explainer

Puritan Bennett 560 ventilators that have been used for more than 14 years of cumulative service may pose health risks due to harmful chemicals released from the device. This recall affects ventilators sold before June 2024 with specific serial numbers. Read more at govinfonow.com/recall/54773-puritan-bennett-560-ventilators-long-term-use-may-cause-health.

Source Summary by GovInfoNow · govinfonow.com/recall/54773-puritan-bennett-560-ventilators-long-term-use-may-cause-health · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2446-2024

Cite this page

“Puritan Bennett 560 Ventilators: Long-term use may cause health risks from VOCs.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54773-puritan-bennett-560-ventilators-long-term-use-may-cause-health. Based on FDA recall #Z-2446-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2446-2024%22&limit=1).

The FDA announced on June 24, 2024, that Covidien is recalling Puritan Bennett 500 Series Ventilators due to a potential health hazard from volatile organic compounds released after extended use. The agency stated that cumulative use exceeding 14 years may pose harm to health.

How to tell if you have it

Puritan Bennett 560 Ventilator/4096600
Puritan Bennett PB560 VENTILATOR EU-DIV/4096600-01
Puritan Bennett 560 Ventilator JAPAN/4096600-02
Puritan Bennett 560 Ventilator APAC/4096600-03
Puritan Bennett 560 Ventilator LATAM/4096600-04
Puritan Bennett 560 Ventilator EMEA/4096600-05
Puritan Bennett 560 Ventilator CAN ANZ/4096600-06
Puritan Bennett 540 Ventilator USA/4097100
Puritan Bennett 520 Ventilator/4098300
Puritan Bennett 520 Ventilator EU-DIV/4098300-01
Puritan Bennett 520 Ventilator Japan/4098300-02
Puritan Bennett 520 Ventilator APAC/4098300-03
Puritan Bennett 520 Ventilator EMEA/4098300-05
Puritan Bennett 520 Ventilator CAN/ANZ/4098300-06
DL4096600 DL PB560 VENTILATOR/DL4096600
DL4096600-06 RFB PB560 VENT CAN ANZ/DL4096600-06
REFURBISHED PB540 VENTILATOR/DL4097100
Puritan Bennett 540 Ventilator Refurbished/DS4097100
All device serial numbers used before distribution of PB500 Series Ventilator User Manual and Clinician's Manual addendum, PT00196729 A, 2024-06-11

The hazard

According to the FDA, using these devices for more than 14 years of cumulative duration may pose harm to health due to a volatile organic compound (VOC), 2-propanol, 1,3-dichloro released from some components in the ventilator gas pathway. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show Covidien has 14 other recalls on record since 2021-03-05. Other recent recalls of similar products include Covidien Bedside SpO2 Monitor Recall (2025-06-23), Covidien Newport HT70 Ventilator Recall (2025-05-21), and Covidien Shiley Tracheostomy Tube Recall (2025-02-26). Other recent recalls of similar products include Ventec V+Pro Ventilator Recall (2026-03-25), Baxter Blue Ventilator Adapter Module Recall (2026-02-18), and Burlington Medical Blockers Recall (2026-02-11).

How to tell if you have this one

Check if your ventilator has a serial number from the list provided in the recall notice. Devices sold before June 2024 with specific regional model numbers (e.g., PB560, PB540, PB520) are affected.

Brand
Puritan Bennett
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Serial Number
Look for the serial number on your ventilator's label or documentation to confirm if it matches the list of affected models and serial numbers in the recall notice.
Review Service Duration
Determine how long your ventilator has been in use, including cumulative service time across multiple devices, to see if it exceeds 14 years.

Where it went and when

Where it was distributed

Distributed in 32 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “US: KY, OH, GA, MN, IN,UT, IL, NJ, NY, PR, LA, MD, MO, TN, MA, ME, CA, SC, AR, TX, WI, PA, CO, MI, NM, RI, VA, DC, VT, NC, NH, WV, NV, IA. OUS: Argentina, Australia, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Cambodia, Canada, Canary…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arkansas, California, Colorado, District of Columbia, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 51 days after the firm started it.

Jun 24, 2024Firm started the recall
Aug 2, 2024FDA classified it Class I
Aug 14, 2024Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using my ventilator immediately?

No, the recall does not require immediate discontinuation. However, you should check if your ventilator meets the criteria for the recall and review its cumulative service duration.

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Link to this recall

<a href="https://govinfonow.com/recall/54773-puritan-bennett-560-ventilators-long-term-use-may-cause-health">Puritan Bennett 560 Ventilators: Long-term use may cause health risks from VOCs (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-2446-2024 (June 24, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2446-2024 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.