Microstream 006324COV-05Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

7 other recalls cover devices cleared under the same FDA submission (K980327); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Feb 17, 2025Open, Classified

   Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.

   Z-1378-2025 · Root cause: Labeling design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K980327. One submission often covers many models, so check the product and lot details in each record.

• Z-1722-2025 · Apr 7, 2025 · Open, Classified
  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
• Z-1333-2012 · Feb 16, 2012 · Terminated
  Oridion CO2 sampling lines and water traps under the label: Surestream CO2 Sampling Lines: SureLine Adult Part No.010976; sureLine Pediatric Part No. 010977; SureLine O2 Ad
• Z-1332-2012 · Feb 16, 2012 · Terminated
  Oridion CO2 sampling lines and water traps under the label: MicroStreamC02 Sampling Lines: FilterLine Set Adult/Pediatric -Part No: XS04620-01; FilterLine Set Adult/Pediatric (
• Z-1350-2012 · Dec 1, 2011 · Terminated
  Oridion Surestream CO2 Sampling Lines- Sure VentLine H Set Adult/Pediatric Part Number: 010987-03 Product Usage: The intended use of SureStream sampling lines is to convey a samp
• Z-2247-2011 · Apr 7, 2011 · Terminated
  Philips Microstream Model M1923A FILTERLINE H SET INF/NEO 25UN PHILIPS These products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates.
• Z-2248-2011 · Apr 7, 2011 · Terminated
  Philips Microstream Model 989803159581 VITALINE H SET INFANT/NEONATAL 25 UN PHILIPS These products are used with Philips Monitors for the measurement of endtidal CO2 in infants an
• Z-2011-2010 · May 26, 2010 · Terminated
  Microstream FILTERLINE H SET ADULT/PEDIATRIC 100 UN Part Number: 010580-01