# FDA recall Z-2446-2024

> **Covidien** · Class I · device recall initiated 2024-06-24.

## Product

Puritan Bennett 500 Series Ventilators (Description/REF):  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

## Reason for 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

## 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 Islands, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Montenegro, Namibia, Nepal, New Zealand, Nigeria, Panama, Poland, Reunion, Romania, Russian Federation, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, Viet Nam, South Africa, Austria, Kenya, Latvia, Lebanon, Mongolia, Nicaragua, Thailand, Tunisia, Algeria, Jordan, Libya, Malawi, Qatar, Pakistan, United Arab Emirates, Oman, Peru, Philippines, Bhutan, Iran - Islamic Republic Of, Bolivia, Kuwait, Egypt, Switzerland, Sudan, Norway, Korea - Republic Of, Bahrain, Ethiopia, Paraguay

## Key facts

- **Recall number:** Z-2446-2024
- **Recalling firm:** Covidien
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-24
- **Report date:** 2024-08-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2446-2024

## Citation

> AI Analytics. FDA recall Z-2446-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2446-2024. Source: US FDA. Licensed CC0.

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