Novalung Sensor Box — Class II medical device recall Z-0562-2022
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2022-02-16, distributed nationwide. Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung Syste
| Recall number | Z-0562-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2021-12-07 |
| Classified | 2022-02-04 |
| Reported by FDA | 2022-02-16 |
| Distributed | Nationwide (US) |
| Quantity | 115 units |
| Serial numbers | XCONUS0001, XCONUS0002, XCONUS0003, XCONUS0004, XCONUS0005, XCONUS0006, XCONUS0007, XCONUS0008, XCONUS0009, XCONUS0010, XCONUS0011, XCONUS0012, XCONUS0013, XCONUS0014, XCONUS0015, XCONUS0016, XCONUS0017, XCONUS0018, XCONUS0019, XCONUS0020, XCONUS0021, XCONUS0022, XCONUS0023, XCONUS0024, XCONUS0025 and 90 more |
Product
Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed,
Reason for recall
Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted communication between flow sensor and sensor box might lead to a disabled flow measurement and air bubble detection.
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-0562-2022. 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.