Recall record at a glance
| Official record | Z-1722-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Philips North America LLC |
| Report date | May 14, 2025 |
| Recall initiation date | Apr 7, 2025 |
| Quantity | 486,631 units |
| Location | Cambridge, MA, United States |
Official product description
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.
Why the product was recalled
Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.