Fresenius Medical Care recalls Novalung sensor boxes (F30000163) that may show error messages #206 or #208 during use, potentially indicating technical failure in long-term respiratory support systems.
Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.
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Contact the company
📍Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 920 · Waltham, MA 02451-1521
“Fresenius Novalung Sensor Box Recall: Error Messages May Indicate Technical Failure.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/55434-fresenius-novalung-sensor-box-recall-error-messages-may-indicate-technical. Based on FDA recall #Z-1822-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1822-2024%22&limit=1).
Fresenius Medical Care Holdings, Inc. voluntarily recalled Novalung sensor boxes (Part Number F30000163) on April 8, 2024, according to the FDA. The devices may experience technical failures causing error messages during use.
How to tell if you have it
Brand: Fresenius Medical Care
Product: Novalung sensor box (component of Novalung Console)
Part Number: F30000163
Serial Numbers: XCONUS0001 to XCONUS0124
The hazard
The recall addresses issues where the Novalung sensor box may exhibit technical failures, resulting in error messages #206 (yellow) and #208 (red) related to flow measurement during use of the Novalung system.
Context
GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since April 14, 2014. Recent recalls include a May 12, 2026 notice for Bicarby Dialysate leaks and a May 11, 2026 recall for 5008X Blood Tubing Set online port errors. Other recent recalls of similar products include a June 30, 2026 Fresenius Medical Care 2008T BlueStar Hemodialysis Machine recall and July 29, 2026 Nova Biomedical StatStrip Glucose Meter System recalls.
How to tell if you have this one
Check if your Novalung sensor box has the product code F30000163 and serial numbers from XCONUS0001 to XCONUS0124. The sensor box is a component of the Novalung Console system used for long-term respiratory support.
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 system display during use.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1822-2024 (April 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1822-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.