Puritan Bennett 500 Series Ventilators — Class I medical device recall Z-2446-2024
Ongoing recall by Covidien, reported 2024-08-14, distributed in AR, CA, CO, DC, GA, IA, IL, IN…. Any single affected ventilator should only be used for the 10- year labelled service life, but if longer venti
| Recall number | Z-2446-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, Carlsbad, CA, United States |
| Recall initiated | 2024-06-24 |
| Classified | 2024-08-02 |
| Reported by FDA | 2024-08-14 |
| Distributed | AR, CA, CO, DC, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, PA, PR, RI, SC, TN, TX, UT, VA, VT, WI, WV |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IR, IT, JO, JP, KE, KR, KW, LB, LT, LV, MX, MY, NG, NI, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PY, QA, RO, SA, SE, SI, SK, TH, TN, TR, TW, UA, VN, ZA |
| Quantity | 34,642 |
| UPC / GTIN / UDI-DI | 10884521087798, 10884521183636, 10884521195943, 10884521195967, 10884521195981, 10884521195998, 10884521196001, 10884521196018, 10884521196025, 10884521196032, 10884521196377, 10884521196384, 10884521786509, 10884521786516 |
| Model numbers | URBISHED/DS4097100 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2446-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.