Use caution Medical device recall · FDA · Published December 7, 2021

Fresenius Novalung Sensor Box Recall: Communication Error Risks Flow Measurement Failure

Fresenius Medical Care recalls Novalung Sensor Box (F30000163) due to potential communication errors between flow sensor and sensor box, which may cause disabled flow measurement and air bubble detection during respiratory support.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0562-2022Medical device Fresenius Medical Care ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 950 · Waltham, MA 02451-1521

✎ GovInfoNow plain-language explainer

Fresenius Medical Care is recalling Novalung Sensor Box components (F30000163) that are part of the Novalung Console system. These devices may show error messages 206 (yellow) or 208 (red) indicating communication issues between the flow sensor and sensor box, which could lead to incorrect flow measurements and air bubble detection during critical respiratory support. Read more at govinfonow.com/recall/61459-fresenius-novalung-sensor-box-recall-communication-error-risks-flow-measurement.

Source Summary by GovInfoNow · govinfonow.com/recall/61459-fresenius-novalung-sensor-box-recall-communication-error-risks-flow-measurement · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0562-2022

Cite this page

“Fresenius Novalung Sensor Box Recall: Communication Error Risks Flow Measurement Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61459-fresenius-novalung-sensor-box-recall-communication-error-risks-flow-measurement. Based on FDA recall #Z-0562-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0562-2022%22&limit=1).

The FDA announced on Dec. 7, 2021, that Fresenius Medical Care Holdings, Inc. is recalling the Novalung Sensor Box (F30000163) due to potential technical failures. The agency said error messages may indicate interrupted communication between components.

How to tell if you have it

Brand: Fresenius Medical Care
Product: Novalung Sensor Box (F30000163), component of Novalung Console (F30000162)
Serial Numbers: XCONUS0013, XCONUS0079, XCONUS0105, XCONUS0036, XCONUS0044, XCONUS0004, XCONUS0014, XCONUS0080, XCONUS0109, XCONUS0021, XCONUS0066, XCONUS0027, XCONUS0017, XCONUS0084, XCONUS0061, XCONUS0043, XCONUS0089, XCONUS0059, XCONUS0019, XCONUS0085, XCONUS0051, XCONUS0047, XCONUS0005, XCONUS0042, XCONUS0020, XCONUS0086, XCONUS0110, XCONUS0055, XCONUS0010, XCONUS0083, XCONUS0022, XCONUS0087, XCONUS0111, XCONUS0064, XCONUS0053, XCONUS0121, XCONUS0023, XCONUS0088, XCONUS0112, XCONUS0002, XCONUS0056, XCONUS0018, XCONUS0024, XCONUS0090, XCONUS0113, XCONUS0003, XCONUS0006, XCONUS0054, XCONUS0030, XCONUS0091, XCONUS0115, XCONUS0007, XCONUS0052, XCONUS0081, XCONUS0032, XCONUS0094, XCONUS0116, XCONUS0012, XCONUS0073, XCONUS0008, XCONUS0039, XCONUS0095, XCONUS0118, XCONUS0070, XCONUS0009, XCONUS0040, XCONUS0096, XCONUS0025, XCONUS0072, XCONUS0001, XCONUS0049, XCONUS0092, XCONUS0026, XCONUS0075, XCONUS0011, XCONUS0058, XCONUS0093, XCONUS0028, XCONUS0082, XCONUS0045, XCONUS0067, XCONUS0097, XCONUS0122, XCONUS0048, XCONUS0065, XCONUS0068, XCONUS0098, XCONUS0123, XCONUS0063, XCONUS0029, XCONUS0069, XCONUS0099, XCONUS0124, XCONUS0031, XCONUS0035, XCONUS0074, XCONUS0100, XCONUS0034, XCONUS0071, XCONUS0046, XCONUS0076, XCONUS0102, XCONUS0038, XCONUS0060, XCONUS0050, XCONUS0077, XCONUS0103, XCONUS0041, XCONUS0062, XCONUS0015, XCONUS0078, XCONUS0104, XCONUS0033, XCONUS0037, XCONUS0016
Units affected: 115

The hazard

The FDA said error messages 206 and 208 indicate a technical failure where communication between the flow sensor and sensor box is interrupted. This interruption might lead to disabled flow measurement and air bubble detection.

Context

GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since April 14, 2014. Other recent recalls of similar products include Fresenius Bicarby Dialysate Leaks Risk (May 12, 2026), Fresenius 5008X Blood Tubing Set Recall (May 11, 2026), and Fresenius Medical Care Bicarby Dialysate Recall (May 7, 2026). Other recent recalls of similar products include Maquet Bubble Sensor Recall (Jan. 9, 2026), Fresenius Medical Care 2008T BlueStar Hemodialysis Machine Recall (June 30, 2026), and Nova Biomedical StatStrip Glucose Meter System Recall (July 29, 2026).

How to tell if you have this one

Check if your Novalung Sensor Box has the serial numbers listed in the recall (e.g., XCONUS0013, XCONUS0079, etc.). The product is part of the Novalung Console system used for long-term respiratory support in adults.

Brand
Fresenius Medical Care
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Error Messages
Look for error messages 206 (yellow) or 208 (red) on the Novalung Console system, which indicate communication issues between the flow sensor and sensor box.
Contact Manufacturer
Reach out to Fresenius Medical Care to confirm if your specific Novalung Sensor Box is affected by the recall and to get instructions for next steps.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 16 states.

FDA distribution: “US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IL, MI, NJ, NV, NY, OK, OR, PA, TN, TX, WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Florida, Illinois, Michigan, Nevada, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, West Virginia.

Recall timeline

FDA published this recall 2 months after the firm started it.

Dec 7, 2021Firm started the recall
Feb 4, 2022FDA classified it Class II
Feb 16, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Fresenius Medical Care recalls

Latest medical device recalls

Keep exploring

More Fresenius Medical Care recalls

Link to this recall

<a href="https://govinfonow.com/recall/61459-fresenius-novalung-sensor-box-recall-communication-error-risks-flow-measurement">Fresenius Novalung Sensor Box Recall: Communication Error Risks Flow Measurement Failure (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0562-2022 (December 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0562-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.