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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Philips Microstream CO2 Filter Lines Recalled for Disconnection Issues

Agency Publication Date: May 5, 2025
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Summary

Philips North America has recalled approximately 486,631 Microstream Advance Neonatal-Infant Intubated CO2 Filter Lines, including various FilterLine and VitaLine models. The recall was issued because the adapter that connects the filter line to the patient's breathing tube may be difficult or impossible to disconnect. While no injuries or incidents have been reported, this defect could interfere with patient care or medical procedures. These devices are typically used in hospital settings to monitor carbon dioxide levels in intubated patients.

Risk

If the adapter cannot be removed from the endotracheal tube, it could delay care or require clinicians to use excessive force, which might accidentally displace the patient's breathing tube. This poses a safety risk, particularly for fragile neonatal and infant patients.

What You Should Do

  1. This recall affects various Philips Microstream Advance and FilterLine carbon dioxide (CO2) filter lines used for intubated neonatal, infant, pediatric, and adult patients.
  2. Identify if your facility has these devices by checking the model numbers and system codes on the device label or packaging. Affected models include 989803204511, 989803204321, 989803204301, 989803204331, and M1920A. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. For further questions or to report issues, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Microstream Advance Neonatal-Infant Intubated CO2 Filter Lines
Variants: Adt/Pedi Intub CO2 Line STerm, Adt/Pedi Intub CO2 Line STerm Lng, Adt/Pedi Intub CO2 Line High Humidity, Adt/Pedi Intub CO2 Line LTerm Lng, Adt/Pedi Intub CO2 Line LTerm, Neo/Inf Intub CO2 Line LTerm, Neo/Inf Intub CO2 Line High Humidity, Neo/Inf Intub CO2 Line LTerm Lng, VitaLine H Set Adult/Pediatric, VitaLine H Set Infant/Neonatal, FilterLine Set Long Adult/Pediatric, FilterLine H Set Long Adult/Pediatric, FilterLine H Set Long Infant/Neonatal, Trade Compliant: FilterLine H, Adult/Ped, Trade Compliant: FilterLine H, Infant/Neo, FilterLine Set Adult/Pedi, FilterLine H Set Adult/Pedi, FilterLine H Set Infant/Neonatal
Model / REF:
989803204511
989803204321
989803204301
989803204331
989803204521
989803204531
989803204311
989803204341
989803159571
989803159581
989803160241
989803160251
989803160261
989803182921
989803182931
989803105531
989803105541
989803105561
M1920A
M1921A
M1923A

Quantity affected: 486,631 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96677
Status: Active
Manufacturer: Philips North America Llc
Sold By: Hospital supply distributors; Medical device retailers
Manufactured In: United States
Units Affected: 486,631 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.