NellcorRecalls & reported problems across all models
Covidien LP · 64 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Nellcor model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,070
- Deaths reported
- 24
- Injuries reported
- 67
- Recalls
- 1
We found 64 models of Nellcor by Covidien LP in the FDA's device registry (GUDID). Together they are named in 1,070 adverse event reports in the FDA's MAUDE database, received between Jul 20, 2017 and Sep 29, 2026 — classified as 24 deaths, 67 injuries, 979 malfunctions.
The most frequently reported specific device problem is “Low Readings” (297 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
Nellcor 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.
- Jun 23, 2025Open, Classified
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting
Z-2151-2025 · Root cause: Labeling design · names 5 of these models · Recall details · FDA record ↗
Most reported Nellcor problems
Device problems
- Low Readings297
- Incorrect Measurement176
- Device Alarm System140
- Patient Device Interaction Problem123
- Image Display Error/Artifact109
- High Readings91
- Temperature Problem89
- Failure to Analyze Signal86
Patient problems
- No Clinical Signs, Symptoms or Conditions494
- Insufficient Information140
- No Consequences Or Impact To Patient130
- No Patient Involvement65
- Burn(s)51
- Pressure Sore/Ulcer51
- Low Oxygen Saturation27
- Injury20
Nellcor models
64 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Nellcor PM10NOximeter2 deaths200 reports
- Nellcor PM100NOximeter1 recall9 deaths142 reports
- Nellcor 10005941Oximeter1 recall3 deaths128 reports
- Nellcor MAXNIOximeter1 death97 reports
- Nellcor 10005941-SGOximeter1 recall46 reports
- Nellcor MAXFASTOximeter61 reports
- Nellcor DLPM100NOximeter1 recall1 report
- Nellcor DL10005941Oximeter1 recall0 reports
- Nellcor MAXIIOximeter1 death36 reports
- Nellcor PM1000NOximeter2 deaths34 reports
- Nellcor MAXNOximeter1 death34 reports
- Nellcor MAXNJOximeter28 reports
- Nellcor D-YSOximeter27 reports
- Nellcor FLEXMAXOximeter20 reports
- Nellcor MAXAOximeter19 reports
- Nellcor DS100AOximeter15 reports
- Nellcor PEDICAPANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE14 reports
- Nellcor DOC10Oximeter1 death13 reports
- Nellcor PM1000N-RROximeter11 reports
- Nellcor FLEXMAX-POximeter9 reports
- Nellcor MAXAJOximeter9 reports
- Nellcor MAXFASTIOximeter8 reports
- Nellcor MAXAIOximeter8 reports
- Nellcor MAXIJOximeter8 reports
- Nellcor MAXFASTOximeter1 death7 reports
- Nellcor N65-1Oximeter6 reports
- Nellcor DS100A-1Oximeter6 reports
- Nellcor N65Oximeter5 reports
- Nellcor GR101704Oximeter5 reports
- Nellcor PMC10GE360NOximeter5 reports
- Nellcor MAXALJOximeter5 reports
- Nellcor N600X-1Oximeter1 death4 reports
- Nellcor RS10Oximeter4 reports
- Nellcor OXI-A/NOximeter4 reports
- Nellcor MAXI-NSOximeter4 reports
- Nellcor MAXPJOximeter4 reports
- Nellcor DLN560Oximeter3 reports
- Nellcor DSN560Oximeter3 reports
- Nellcor MAXN-NSOximeter3 reports
- Nellcor MAXNROXIMETER, REPROCESSED3 reports
- Nellcor OXI-P/IOximeter3 reports
- Nellcor PMC10NFH-GEOximeter2 reports
- Nellcor MAXFASTIOximeter2 reports
- Nellcor D-YSEOximeter2 reports
- Nellcor 904-NOximeter2 reports
- Nellcor N25Oximeter2 reports
- Nellcor EASYCAP IIANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 report
- Nellcor 10076644Oximeter1 report
- Nellcor POSEYOximeter1 report
- Nellcor DLPM1000NOximeter1 report
- Nellcor PMC10GE360NOximeter1 report
- Nellcor EASYCAP II 6ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 report
- Nellcor PMC10NCH-GEOximeter1 report
- Nellcor MAXAL-NSOximeter1 report
- Nellcor SC-PROximeter1 report
- Nellcor SC-PR-IOximeter1 death1 report
- Nellcor MAXAROXIMETER, REPROCESSED1 report
- Nellcor MAXIOximeter1 report
- Nellcor MAXPOximeter1 report
- Nellcor SC-NEOOximeter1 death1 report
- Nellcor SC-NEO-IOximeter1 report
- Nellcor 10005063Oximeter1 report
- Nellcor D25Oximeter1 report
- Nellcor D25LOximeter1 report
Recent Nellcor adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure to Analyze Signal; Delayed Program or Algorithm Execution
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940430 ↗MalfunctionSep 21, 2026Incorrect Measurement
Patient problems: Insufficient Information
MAUDE report 50849216 ↗InjuryJul 1, 2026Incorrect Measurement
IT WAS REPORTED THAT A PATIENT IN THE ICU WAS BEING MONITORED WITH A FOREHEAD SPO2 PROBE AND WAS TRANSPORTED TO THE ENDOSCOPY SUITE FOR A PROCEDURAL SEDATION AND ERCP PROCEDURE. DURING TRANSPORT, THROUGHOUT THE PROCEDURE, AND FOLLOWING THE PROCEDURE, THE SPO2 PROBE INTERMITTENTLY FAILED TO PROVIDE A RELIABLE READING. THE WAVEFORM WAS POOR AND DID NOT CORRELATE WITH THE ARTERIAL LINE READINGS. THE SIGNAL QUALITY WORSENED DURING AND AFTER THE PROCEDURE. DUE TO THE UNRELIABLE READINGS, THE PATIENT¿S OXYGENATION WAS ASSESSED USING CLINICAL SIGNS SUCH AS GUM COLOR AND CHEST RISE. A NASAL SPO2 PROBE AND CABLE WERE BROUGHT DURING TRANSPORT AND BRIEFLY TRIALED DURING THE PROCEDURE; HOWEVER, NO WAVEFORM OR NUMERIC READING WAS OBTAINED, AND THE DEVICE WAS NOT USED FURTHER. THROUGHOUT THE PROCEDURE THE PATIENT¿S BLOOD PRESSURE REMAINED ADEQUATE, WITH SYSTOLIC BLOOD PRESSURE RANGING BETWEEN 90 AND 110 MMHG, AND CENTRAL PERFUSION APPEARED SUFFICIENT. DURING TRANSPORT BACK TO THE ICU, THE FOREHEAD SPO2 PROBE DISPLAYED READINGS BETWEEN 83¿88% WITH A POOR WAVEFORM. AT THAT TIME THE PATIENT WAS OBSERVED TO BE CENTRALLY CYANOTIC. THE PATIENT CONTINUED BREATHING WITHOUT OBSERVED APNEA OR SNORING. A R
Patient problems: Cyanosis; Low Oxygen Saturation
MAUDE report 25675280 ↗MalfunctionJun 20, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT AFTER USING THE SENSOR, SKIN REDNESS (ERYTHEMA) WAS OBSERVED ON THE SOLE OF THE PATIENT'S FOOT.
Patient problems: Erythema
MAUDE report 25569062 ↗MalfunctionJun 9, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT DURING APPLICATION, SKIN LESION OCCURRED. THE SEAMS OF THE SENSOR FELT A LITTLE HARDER THAN OTHER SENSORS.
Patient problems: Localized Skin Lesion
MAUDE report 25451471 ↗MalfunctionJun 9, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT DURING USE OF THE SENSOR, THE PATIENT HAD BURN INJURY. THE SENSOR WAS NEEDED TO BE REPOSITIONED EVERY 3-4 HOURS. THE BURN INJURY CAUSED BY THE SENSOR IS LOCATED AROUND THE EDGES OF THE SENSOR REGION.
Patient problems: Burn(s)
MAUDE report 25448982 ↗MalfunctionJun 2, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT DURING USE OF THE SENSOR, THE PATIENT HAD BURN INJURY IN THE LEFT THUMB. THE SENSOR WAS NEEDED TO BE REPOSITIONED EVERY 3-4 HOURS. THE BURN INJURY CAUSED BY THE SENSOR IS LOCATED AROUND THE EDGES OF THE SENSOR REGION. AFTERWARD, A DIFFERENT SENSOR MODEL WAS ATTACHED TO THE INDEX TOE OF RIGHT FOOT, BUT A BURN OCCURRED WITH THE SENSOR AS WELL.
Patient problems: Burn(s)
MAUDE report 25360896 ↗MalfunctionJun 1, 2026Device Alarm System; Data Problem
IT WAS REPORTED THAT A DEVICE WAS OBSERVED WHILE PREPARING FOR USE TO NOT HOLD THE DATE AND TIME (TIME CLOCK ISSUE). THERE WERE NO AUDIBLE AND VISUAL ALARMS. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25349685 ↗MalfunctionMay 29, 2026Failure to Analyze Signal; Low Readings
IT WAS REPORTED THAT, DURING USE, THE DEVICE WAS TAKING TOO LONG TO OBTAIN A READING AND WAS READING LOW OR INCORRECTLY WITH REPORTED VALUES OF SPO2 77 AND PULSE RATE 22. SENSOR WAS PLACED CORRECTLY AND PATIENT WAS IN SEATED POSITION. THE USER TESTED THE SENSOR ON THEMSELVES AND OBSERVED THE SAME READINGS. SENSORS WERE SWAPPED OUT TO ISOLATE FAILURE. THE USER SWITCHED MONITORS AND NOTICED THE OTHER PULSE OX MONITOR WAS READING PROPERLY. THE MONITOR WAS THEN TURNED ON AND OFF TO RESET IT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25333454 ↗MalfunctionMay 29, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT DURING APPLICATION, SKIN REDNESS ON THE SOLES OF THE FEET CONSISTENT WITH A SKIN LESION, WAS OBSERVED. IT WAS ALSO NOTED THAT THE SEAMS OF THE SENSOR FELT HARD DURING USE.
Patient problems: Localized Skin Lesion
MAUDE report 25330481 ↗MalfunctionMay 29, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT DURING APPLICATION, SKIN REDNESS OCCURS ON THE SOLES OF THE FEET, CONSISTENT WITH A SKIN LESION. IT WAS ALSO NOTED THAT THE SEAMS OF THE SENSOR FELT A LIITLE HARDER.
Patient problems: Localized Skin Lesion
MAUDE report 25330418 ↗MalfunctionMay 20, 2026Device Alarm System; Low Readings
DURING INTRAOPERATIVE USE, THE MONITOR DID NOT READ CORRECTLY FOR A NEONATE/PEDIATRIC PATIENT, AND LOW OXIMETRY READINGS WERE OBSERVED. NO ALARM OCCURRED AT THE TIME THE ISSUE WAS NOTED. COMPATIBILITY OF THE CABLES USED WITH THE UNIT WAS CONSIDERED AS A POSSIBLE FACTOR. TROUBLESHOOTING WAS PERFORMED, INCLUDING CHECKING PROPER PATIENT SENSOR PLACEMENT, CONSIDERING THE EFFECTS OF LIGHT-EMITTING DIODE (LED) LIGHTING AND PATIENT MOVEMENT, INSPECTING THE SENSOR, AND CONFIRMING THE SENSOR AGE (FROM 2019). A REPLACEMENT SENSOR WAS SUGGESTED TO DETERMINE WHETHER THE READINGS WOULD CHANGE. THE PATIENT TYPE AND WEIGHT SETTINGS ON THE DEVICE WERE ALSO VERIFIED. A REFERENCE GUIDE FOR SENSORS AND PLACEMENT, ALONG WITH INSTRUCTIONS FOR USE INFORMATION, WAS PROVIDED VIA EMAIL. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25229045 ↗MalfunctionMay 18, 2026Device Alarm System; Low Readings
IT WAS REPORTED THAT DURING INTRAOPERATIVE USE, THE MONITOR DID NOT READ CORRECTLY FOR A NEONATE/PEDIATRIC PATIENT, AND LOW OXIMETRY READINGS WERE OBSERVED. NO ALARM OCCURRED AT THE TIME THE ISSUE WAS NOTED. COMPATIBILITY OF THE CABLES USED WITH THE UNIT WAS CONSIDERED AS A POSSIBLE FACTOR. TROUBLESHOOTING WAS PERFORMED, INCLUDING CHECKING PROPER PATIENT SENSOR PLACEMENT, CONSIDERING THE EFFECTS OF LIGHT-EMITTING DIODE (LED) LIGHTING AND PATIENT MOVEMENT, INSPECTING THE SENSOR, AND CONFIRMING THE SENSOR AGE (FROM 2019). A REPLACEMENT SENSOR WAS SUGGESTED TO DETERMINE WHETHER THE READINGS WOULD CHANGE. THE PATIENT TYPE AND WEIGHT SETTINGS ON THE DEVICE WERE ALSO VERIFIED. A REFERENCE GUIDE FOR SENSORS AND PLACEMENT, ALONG WITH INSTRUCTIONS FOR USE INFORMATION, WAS PROVIDED VIA EMAIL. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25210064 ↗MalfunctionMay 4, 2026Incorrect Measurement
IT WAS REPORTED THAT, DURING USE, THERE WAS A DEFECT IN DISPLAYING THE HEART RATE AND OXYGEN SATURATION READINGS. THE ISSUE OCCURRED TWICE WITH TWO SENSORS. AN URGENT SENSOR CHANGE AND URGENT SCOPE CHANGE WERE PERFORMED, AND A SENSOR OF THE SAME REFERENCE WAS THEN USED TO COMPLETE THE ACT. THERE WAS A DELAY IN PATIENT CARE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25069063 ↗MalfunctionMay 4, 2026Incorrect Measurement
IT WAS REPORTED THAT, DURING USE, THERE WAS A DEFECT IN DISPLAYING THE HEART RATE AND OXYGEN SATURATION READINGS. THE ISSUE OCCURRED TWICE WITH TWO SENSORS. AN URGENT SENSOR CHANGE AND URGENT SCOPE CHANGE WERE PERFORMED, AND A SENSOR OF THE SAME REFERENCE WAS THEN USED TO COMPLETE THE ACT. THERE WAS A DELAY IN PATIENT CARE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25069042 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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