Covidien 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 Ve Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 Ve
Brand
Covidien
Lot Codes / Batch Numbers
PT00196729 A, 2024-06-11
Products Sold
REF/UDI-DI(GTIN): 4096600/10884521087798 4096600-01/10884521195998 4096600-02/10884521196001 4096600-03/10884521196018 4096600-04/10884521196025 4096600-05/10884521196032 4096600-06/10884521196377 4097100/4097100 4098300/10884521183636 4098300-01/10884521195943 4098300-02/4098300-02 4098300-03/10884521195967 4098300-05/10884521195981 4098300-06/10884521196384 DL4096600/10884521786509 DL4096600-06/10884521786516 DL4097100/DL4097100 DS4097100/DS4097100 All device serial numbers used before distribution of PB500 Series Ventilator User Manual and Clinician's Manual addendum, PT00196729 A, 2024-06-11
Covidien is recalling Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PU due to Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
On 6/27/24, Medtronic started correction notice distribution to physicians, health care professionals, distributors, and users who were advised of the following: 1) Any single PB500 series ventilator should only be used for the 10-year labelled service life. If a patient requires ventilatory support for a longer period of time, cumulative sequential use of more than one PB500 series ventilator should be limited to 14 years. After 14 years of cumulative use, patients should be transitioned to an alternate device. 2) When approaching 14 years of cumulative use of a PB500 series ventilator, it is recommended that patients or their caregivers discuss transitioning to an alternate ventilator with the prescribing physician. 3) Review the correction notice information with all members of your staff who need to be aware of the contents of this communication. 4) Provide the correction notice to those who need to be aware within your organization or to any organization or person where the product has been transferred or distributed. 5) Medtronic has updated the labeling. Please refer to the User Manual and Clinician s Manual addendum 6) Complete and return the response form via email to rs.gmbmitgfca@medtronic.com If you have any questions regarding this communication, please contact your Medtronic Representative or Technical Service at 1-800- 255-6774.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, CA, CO, GA, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MO, NV, NH, NJ, NM, NY, NC, OH, PA, RI, SC, TN, TX, UT, VT, VA, WV, WI, DC, PR
Page updated: Jan 10, 2026