MicrostreamRecalls & reported problems across all models
Oridion Medical 1987 Ltd. · 21 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Microstream model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 102
- Deaths reported
- 1
- Injuries reported
- 4
- Recalls
- 3
We found 21 models of Microstream by Oridion Medical 1987 Ltd. in the FDA's device registry (GUDID). Together they are named in 102 adverse event reports in the FDA's MAUDE database, received between Nov 2, 2017 and Mar 19, 2026 — classified as 1 death, 4 injuries, 97 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (30 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Microstream recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 17, 2025Class IIOpen, 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 · names 2 of these models · Recall details · FDA record ↗
- Feb 17, 2025Class IIOpen, 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-1377-2025 · Root cause: Labeling design · names 7 of these models · Recall details · FDA record ↗
- Feb 17, 2025Class IIOpen, 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-1376-2025 · Root cause: Labeling design · names 3 of these models · Recall details · FDA record ↗
Most reported Microstream problems
Device problems
- Device Alarm System30
- Incorrect Measurement22
- Temperature Problem14
- High Readings13
- Low Readings13
- Failure to Calibrate7
- Data Problem6
- Failure to Power Up6
Patient problems
- No Clinical Signs, Symptoms or Conditions82
- Insufficient Information11
- No Patient Involvement8
- Death2
- No Consequences Or Impact To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Chest Pain1
- Cyanosis1
Microstream models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Microstream 015328Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase1 recall2 reports
- Microstream 006330ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream 015553ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream 015705_RMS1ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream 010808ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream 015707_RMS1ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream 007907ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream XS04624COV-05ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream 006324COV-05ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream 011108Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase1 recall0 reports
- Microstream 015281_RMS1ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream 015227_RMS1ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall0 reports
- Microstream PM35MN02ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE36 reports
- Microstream CS08651-02ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE23 reports
- Microstream PM35MN01ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE15 reports
- Microstream CS08651-03ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 death15 reports
- Microstream CS08657-02ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE6 reports
- Microstream 015715_RMS1ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE2 reports
- Microstream 015183Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase1 report
- Microstream 010597ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 report
- Microstream 015179_RMS1Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase1 report
Recent Microstream adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2026Failure to Run on Battery; High Readings
IT WAS REPORTED THAT PRIOR TO USE, THE BATTERY AVAILABILITY FAILED AND THE ETCO2 VALUE WAS HIGHER THAN EXPECTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637204 ↗MalfunctionJan 26, 2026Device Alarm System; Failure to Analyze Signal; Data Problem
IT WAS REPORTED THAT PRIOR TO USE, THE UNIT¿S SPO2 READING WAS FOUND DROPPING. ALSO, THE UNIT WOULD NOT HOLD DATE AND TIME. THERE WAS NO AUDIBLE OR VISUAL ALARM WHEN THE ISSUES OCCURRED. THE CUSTOMER SWAPPED SEVERAL CABLES AND SENSORS, BUT THE ISSUE PERSISTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24177510 ↗MalfunctionJan 21, 2026Device Alarm System; Failure to Calibrate
IT WAS REPORTED THAT, DURING PRE-OPERATIVE PREPARATION FOR USE, THE DEVICE WOULD NOT CALIBRATE AND FAILED THE POWER ON SELF TEST (POST). NO AUDIBLE OR VISUAL ALARM WAS PRESENTED FOR THE FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24140477 ↗MalfunctionJan 21, 2026Device Alarm System; Failure to Calibrate
IT WAS REPORTED THAT, DURING PRE-OPERATIVE PREPARATION FOR USE, THE DEVICE FAILED CALIBRATION. THERE WAS NO AUDIBLE OR VISUAL ALARM PRESENTED FOR THE FAILURE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24140377 ↗MalfunctionJan 20, 2026Device Alarm System
IT WAS REPORTED THAT THE SPO2 ALARM ON THE DEVICE DID NOT ACTIVATE WHEN OXYGEN SATURATION REACHED ITS LOWER LIMITS DURING PRE-OPERATIVE PREPARATION. THE DEVICE ALARM FAILED WHEN THE ISSUE OCCURRED. THE DEVICE WAS TESTED BEFORE USE, AND THE LOWER AND HIGH ALARMS WERE UPDATED. THERE WAS AN VISUAL BUT NO AUDIBLE ALARM. TROUBLESHOOTING STEPS INCLUDED TESTING THE DEVICE AND UPDATING ALARM SETTINGS, AS WELL AS SWAPPING TO ISOLATE THE ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24116288 ↗MalfunctionDec 30, 2025Device Alarm System; Image Display Error/Artifact; Data Problem; Device Alarm System; Image Display Error/Artifact; Data Problem
IT WAS REPORTED THAT THE DEVICE HAD AN SPO2 ERROR, WAS NOT HOLDING TIME AND THE CONFIRMED EQUIVALENT TO DATE IS INVALID. THERE WAS NO AUDIBLE OR VISUAL ALARM PRESENTED. SWAPPED TO ISOLATE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23922416 ↗MalfunctionOct 29, 2025Device Alarm System; Failure to Run on Battery; Data Problem; Device Alarm System; Failure to Run on Battery; Data Problem
IT WAS REPORTED THAT, DURING PRE-OPERATIVE PREPARATION FOR USE, BATTERY EXPIRATION WAS IDENTIFIED. THE DEVICE WOULD NOT HOLD THE DATE AND TIME. NO AUDIBLE VISUAL ALARM WAS PRESENTED FOR THE FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23421026 ↗MalfunctionOct 29, 2025Device Alarm System; Failure to Run on Battery; Data Problem; Device Alarm System; Failure to Run on Battery; Data Problem
IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION FOR USE, THE BATTERY WAS DEPLETED. THE DEVICE WOULD NOT HOLD THE DATE AND TIME. NO AUDIBLE VISUAL ALARM WAS PRESENTED FOR THE FAILURE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23421025 ↗MalfunctionOct 29, 2025Device Alarm System; Failure to Run on Battery; Data Problem; Device Alarm System; Failure to Run on Battery; Data Problem
IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION FOR USE, THE BATTERY WAS DEPLETED. THE DEVICE WOULD NOT HOLD THE DATE AND TIME. NO AUDIBLE VISUAL ALARM WAS PRESENTED FOR THE FAILURE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23421006 ↗MalfunctionSep 10, 2025Device Alarm System; Charging Problem; Device Alarm System; Charging Problem
IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION FOR USE, THE DEVICE DID NOT TAKE CHARGE EVEN AFTER THE BATTERY WAS SWAPPED. NO ALARM WAS PRESENTED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23013355 ↗MalfunctionSep 3, 2025Device Alarm System; Display or Visual Feedback Problem; Device Alarm System; Display or Visual Feedback Problem
IT WAS REPORTED THAT PRIOR TO USE, THE MONITOR'S BACKLIGHT WAS NOT WORKING. NO TROUBLESHOOTING STEPS WERE DONE TO ISOLATE THE FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22956892 ↗MalfunctionSep 3, 2025Device Alarm System; Failure of Device to Self-Test; Device Alarm System; Failure of Device to Self-Test
IT WAS REPORTED THAT DURING TESTING AND MAINTENANCE OF THE MONITOR, A DISPLAYED MESSAGE INDICATING SFM DATA INTEGRITY FAILED AND FAILED TO COMPLETE THE POWER ON SELF TEST (POST). THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22950089 ↗MalfunctionSep 2, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE NICU DUE TO NEONATAL DISTRESS. THE INFANT WAS PLACED ON INVASIVE VENTILATOR SUPPORT WITH CONTINUOUS MONITORING OF END-TIDAL CARBON DIOXIDE (ETCO2) LEVELS. AT APPROXIMATELY 5:00 PM, ETCO2 READINGS WERE WITHIN NORMAL LIMITS. HOWEVER, DURING A ROUTINE CHECK AT 9:00 PM, THE ATTENDING PHYSICIAN FOUND THAT THE MONITOR NO LONGER DISPLAYED ETCO2 READINGS. RECONNECTION OF THE SAMPLING TUBE DID NOT RESOLVE THE ISSUE. THE SAMPLING TUBE WAS THEN REPLACED WITH A NEW ONE, AFTER WHICH NORMAL ETCO2 MONITORING RESUMED. THE INFANT'S VITAL SIGNS REMAINED STABLE, AND NO ADVERSE OUTCOMES OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22937495 ↗MalfunctionAug 20, 2025Device Alarm System; Image Display Error/Artifact; Failure of Device to Self-Test; Device Alarm System; Image Display Error/Artifact; Failure of Device to Self-Test
IT WAS REPORTED THAT THE UNIT DISPLAYED THE MESSAGE "POSTOS: SFM DATA INTEGRITY FAILED, LAUNCHING UPGRADE" AND DID NOT COMPLETE THE POWER ON SELF TEST (POST) DURING PRE-OPERATIVE PREPARATION. THERE WAS NO ALARM HEARD WHEN THE ISSUE OCCURRED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22850514 ↗MalfunctionAug 1, 2025Device Alarm System; Image Display Error/Artifact; Failure of Device to Self-Test; Device Alarm System; Image Display Error/Artifact; Failure of Device to Self-Test
IT WAS REPORTED THAT THE UNIT DISPLAYED THE MESSAGE: 'POSTOS: SFM DATA INTEGRITY FAILED, LAUNCHING UPGRADE,' AND DID NOT COMPLETE THE POWER-ON SELF-TEST (POST) DURING PRE-OPERATIVE PREPARATION FOR USE. ADDITIONALLY, THERE WAS NO AUDIBLE ALARM WHEN THE MALFUNCTION OCCURRED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22691154 ↗
Other Oridion Medical 1987 Ltd. products
All Oridion Medical 1987 Ltd. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page