HUDSON RCIRecalls & reported problems across all models
Medline Industries, Inc. · 30 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one HUDSON RCI model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 190
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 2
We found 30 models of HUDSON RCI by Medline Industries, Inc. in the FDA's device registry (GUDID). Together they are named in 190 adverse event reports in the FDA's MAUDE database, received between Jul 14, 2024 and Sep 30, 2026 — classified as 8 injuries, 182 malfunctions.
The most frequently reported specific device problem is “Unexpected Shutdown” (34 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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
HUDSON RCI 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.
- Jul 13, 2026Class IIOpen, Classified
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.
Z-2993-2026 · Root cause: Under Investigation by firm · names 6 of these models · Recall details · FDA record ↗
- Nov 21, 2025Class IIOpen, Classified
Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.
Z-1035-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported HUDSON RCI problems
Device problems
- Unexpected Shutdown34
- Detachment of Device or Device Component33
- Loose or Intermittent Connection19
- Insufficient Heating17
- Excessive Heating12
- Melted9
- Device Alarm System8
- Overheating of Device7
Patient problems
- No Clinical Signs, Symptoms or Conditions172
- Low Oxygen Saturation6
- Hypoxia4
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Burn(s)1
- Choking1
- Cough1
HUDSON RCI models
30 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HUDSON RCI HUD42500HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)87 reports
- HUDSON RCI HUDRHO41UMASK, OXYGEN1 recall27 reports
- HUDSON RCI HUD88015KITHumidifier nebulizer kit1 recall15 reports
- HUDSON RCI HUD1930MASK, OXYGEN1 recall12 reports
- HUDSON RCI HUD88017KITHumidifier nebulizer kit1 recall0 reports
- HUDSON RCI HUD88014KITHumidifier nebulizer kit1 recall0 reports
- HUDSON RCI HUD88013KITHumidifier nebulizer kit1 recall0 reports
- HUDSON RCI HUD78001KITHumidifier nebulizer kit1 recall0 reports
- HUDSON RCI HUD78018KITHumidifier nebulizer kit1 recall0 reports
- HUDSON RCI HUD05014Nebulizer (direct patient interface)6 reports
- HUDSON RCI HUDRHP340UHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)6 reports
- HUDSON RCI HUD00540HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)6 reports
- HUDSON RCI HUD1060MASK, OXYGEN, NON-REBREATHING5 reports
- HUDSON RCI HUD1007MASK, OXYGEN4 reports
- HUDSON RCI HUD1059MASK, OXYGEN, NON-REBREATHING3 reports
- HUDSON RCI HUD1820CANNULA, NASAL, OXYGEN2 reports
- HUDSON RCI HUD87098KITHumidifier nebulizer kit2 reports
- HUDSON RCI HUD1115TUBING, PRESSURE AND ACCESSORIES2 reports
- HUDSON RCI HUD1607Circuit, breathing (w connector, adaptor, y piece)2 reports
- HUDSON RCI HUD1827CANNULA, NASAL, OXYGEN1 report
- HUDSON RCI HUD2410HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)1 report
- HUDSON RCI HUD1936MASK, OXYGEN, NON-REBREATHING1 report
- HUDSON RCI HUD3230HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)1 report
- HUDSON RCI HUD1870CANNULA, NASAL, OXYGEN1 report
- HUDSON RCI HUD8884719010SPIROMETER, THERAPEUTIC (INCENTIVE)1 report
- HUDSON RCI HUD88009KITHumidifier nebulizer kit1 report
- HUDSON RCI HUD1009MASK, OXYGEN1 report
- HUDSON RCI HUD1077TUBING, PRESSURE AND ACCESSORIES1 report
- HUDSON RCI HUD1613Circuit, breathing (w connector, adaptor, y piece)1 report
- HUDSON RCI HUD42500RHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)1 report
Recent HUDSON RCI adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953810 ↗MalfunctionSep 30, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952831 ↗MalfunctionSep 30, 2026Power Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952828 ↗MalfunctionSep 30, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952347 ↗MalfunctionSep 30, 2026Break
It was reported that "THE UNIT IS BROKEN".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952341 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component; Excessive Heating
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952337 ↗MalfunctionSep 30, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951045 ↗MalfunctionSep 30, 2026Excessive Heating
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950993 ↗MalfunctionSep 30, 2026Insufficient Heating
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950824 ↗MalfunctionSep 30, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950667 ↗MalfunctionSep 30, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950441 ↗MalfunctionSep 30, 2026Failure to Power Up
It was reported that the unit will not power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949823 ↗MalfunctionSep 30, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948560 ↗MalfunctionSep 30, 2026Loose or Intermittent Connection; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948549 ↗MalfunctionSep 30, 2026Excessive Heating
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948358 ↗
Other Medline Industries, Inc. products
- Centurion Medical Products Corp52 models · 10 reports · 32 recalls
- NAMIC667 models · 229 reports · 22 recalls
- CURAD85 models · 295 reports · 4 recalls
- Excelsior8 models · 47 reports · 3 recalls
- BAUSCH and LOMB6 models · 1 reports · 2 recalls
- Medline ReNewal18 models · 34 reports · 1 recall
- Guardian15 models · 77 reports
- MEDLINE UNITE10 models · 9 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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