Product Name: AVEA¿ Ventilator — Class I medical device recall Z-2273-2013
Terminated recall by Carefusion 211 Inc dba Carefusion, reported 2013-10-09, distributed nationwide. CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher altitudes. A
| Recall number | Z-2273-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carefusion 211 Inc dba Carefusion, Yorba Linda, CA, United States |
| Recall initiated | 2013-09-05 |
| Classified | 2013-09-27 |
| Reported by FDA | 2013-10-09 |
| Terminated | 2015-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BD, BE, BH, BM, BO, BR, BZ, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DO, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IT, JO, JP, KR, KW, LB, LT, LV, MA, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, SA, SG, SI, SK, SV, TH, TN, TR, TW |
| Quantity | 19,546 units |
| Serial numbers | ACV01035, ACV01054, ACV01058, ACV01061, ACV01092, ACV01099, ACV01500, ACV01501, ACV01503, ACV01504, ACV01505, ACV01510, ACV01511, ACV01512, ACV01515, ACV01519, ACV01525, ACV01526, ACV01529, ACV01537, ACV01538, ACV01539, ACV01540, ACV01542, ACV01545 and 475 more |
Product
Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
Reason for recall
CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a field correction of the affected devices to correct the error.
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-2273-2013. 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.