CLASS II ONGOING Device recall · Reported 14 May 2025 · FDA Enforcement Report

Microstream Advance Neonatal-Infant Intubated CO2 Filter recalled

Philips North America is recalling Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub, distributed nationwide in the US. The recall was initiated on 7 Apr 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. 989803204511, 989803204321, 989803204301, 989803204331, 989803204521, 989803204531, 989803204311, 989803204341, 989803159571, 989803159581, 989803160241, 989803160251, 989803160261, 989803182921, 989803182931, 989803105531, 989803105541, 989803105561; UDI: N/A; System Codes 989803105531, 989803105541, 989803105561, 989803159581, 989803160241, 989803160251, 989803160261, 989803182921, 989803182931, 989803204301, 989803204311, 989803204321, 989803204331, 989803204341, 989803204511, 989803204521, 989803204531, 989803159571, 989803159581, 989803160241, 989803160251, 989803160261, 989803182921, 989803182931, 989803204301, 989803204311, 989803204321, 989803204331, 989803204341, 989803204511, 989803204521, 989803204531, M1920A, M1921A, M1923A.

Quantity recalled486,631 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1722-2025
FDA event ID: 96677
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 7 Apr 2025
FDA classified: 5 May 2025
Reported: 14 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

7 Apr 2025	Recall initiated by company
5 May 2025	Classified by FDA	+28 days
14 May 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.

Product as listed by the FDA

Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as 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 and FilterLine H Set Infant/Neonatal. Carbon dioxide gas analyzer.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of AE, AL, AO, AR, AT, AU, AW, BD, BE, BG, BH, BO, BR, BW, BY, CA, CD, CH, CI, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, ET, FI, FJ, FO, FR, GA, GB, GF, GH, GI, GP, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KE, KG, KR, KW, LB, LK, LT, LU, LV, LY, MA, MC, MM, MO, MQ, MT, MU, MV, MX, MY, MZ, NC, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PG, PH, PK, PL, PM, PR, PS, PT, PY, QA, RE, RO, RS, RU, RW, SA, SE, SG, SI, SK, SN, SY, TH, TN, TR, TT, TW, TZ, UA, UY, VA, VN, YT, ZA.

Nationwide Alabama Arkansas California Colorado Delaware Georgia Idaho Illinois Indiana Massachusetts Missouri Montana North Carolina Pennsylvania Puerto Rico Tennessee Virginia

Questions about this recall

Why was it recalled?

Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.

Which lots are affected?

Model No. 989803204511, 989803204321, 989803204301, 989803204331, 989803204521, 989803204531, 989803204311, 989803204341, 989803159571, 989803159581, 989803160241, 989803160251, 989803160261, 989803182921, 989803182931, 989803105531, 989803105541, 989803105561; UDI: N/A; System Codes 989803105531, 989803105541, 989803105561, 989803159581, 989803160241, 989803160251, 989803160261, 989803182921, 989803182931, 989803204301, 989803204311, 989803204321, 989803204331, 989803204341, 989803204511, 989803204521, 989803204531, 989803159571, 989803159581, 989803160241, 989803160251, 989803160261, 989803182921, 989803182931, 989803204301, 989803204311, 989803204321, 989803204331, 989803204341, 989803204511, 989803204521, 989803204531, M1920A, M1921A, M1923A.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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