Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported February 16, 2022
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,
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 …
Fresenius Medical Care Holdings, Inc. recalled Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated f… — a moderate-severity action.
Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated f… was recalled by Fresenius Medical Care Holdings, Inc. in February 16, 2022. Reason: Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung Syst…. Check the official notice for the remedy. Verify recall #Z-0562-2022 with the FDA Devices before acting.
The recall
Fresenius Medical Care Holdings, Inc. issued this moderate-severity FDA Devices recall — Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung Syst….
- Moderate
- severity level
- 115 units
- affected scope
- Class II
- classification
- February 16, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0562-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0562-2022) was formally reported on February 16, 2022, with the manufacturer initiating the action on December 7, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Fresenius Medical Care Holdings, Inc. is listed as the recalling firm, operating out of Waltham, MA. Federal records list the affected scope as 115 units.
The documented reason for this recall is: 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 communicatio… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IL, MI, NJ, NV, NY, OK, OR, PA, TN, TX, WV.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
115 units
Related Recalls
6
6 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0562-2022 |
| Date reported | February 16, 2022 |
| Date initiated | December 7, 2021 |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Firm location | Waltham, MA |
| Affected scope | 115 units |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IL, MI, NJ, NV, NY, OK, OR, PA, TN, TX, WV. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0562-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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,. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 115 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 16, 2022. Severity: Moderate. Recall number: Z-0562-2022.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IL, MI, NJ, NV, NY, OK, OR, PA, TN, TX, WV..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0562-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported February 16, 2022.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.