HUDSON RCIRecalls & reported problems across all models

We found 152 models of HUDSON RCI by Teleflex Incorporated in the FDA's device registry (GUDID). Together they are named in 1,461 adverse event reports in the FDA's MAUDE database, received between Feb 26, 2018 and Sep 29, 2026 — classified as 8 deaths, 68 injuries, 1,383 malfunctions.

The most frequently reported specific device problem is “Break” (176 reports).

7 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

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.

1. Apr 11, 2022Open, Classified

   Reports received of torn corrugated breathing tubes.

   Z-1127-2022 · Root cause: Device Design · names 4 of these models · Recall details · FDA record ↗

2. Apr 11, 2022Open, Classified

   Reports received of torn corrugated breathing tubes.

   Z-1126-2022 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

3. Dec 13, 2019Terminated

   There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

   Z-1115-2020 · Root cause: Device Design · Recall details · FDA record ↗

4. Dec 13, 2019Terminated

   There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

   Z-1114-2020 · Root cause: Device Design · Recall details · FDA record ↗

5. Dec 13, 2019Terminated

   There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

   Z-1113-2020 · Root cause: Device Design · Recall details · FDA record ↗

6. Dec 13, 2019Terminated

   There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

   Z-1112-2020 · Root cause: Device Design · Recall details · FDA record ↗

7. May 10, 2019Terminated

   Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.

   Z-1912-2019 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

Most reported HUDSON RCI problems

HUDSON RCI models

152 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

• HUDSON RCI IPN913776

  HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
  436 reports
• HUDSON RCI IPN043837

  SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
  1 recall18 reports
• HUDSON RCI IPN048996

  TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
  64 reports
• HUDSON RCI IPN049807

  NEBULIZER (DIRECT PATIENT INTERFACE)
  62 reports
• HUDSON RCI IPN048995

  TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
  58 reports
• HUDSON RCI IPN913728

  HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
  1 recall4 reports
• HUDSON RCI IPN042780

  CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
  1 recall3 reports
• HUDSON RCI IPN042781

  CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
  1 recall1 report
• HUDSON RCI IPN913729

  HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
  1 recall1 report
• HUDSON RCI IPN913730

  Humidifier nebulizer kit
  1 recall1 report
• HUDSON RCI IPN044019

  SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
  1 recall0 reports
• HUDSON RCI IPN044020

  SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
  1 recall0 reports
• HUDSON RCI IPN044039

  SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
  1 recall0 reports
• HUDSON RCI IPN046879

  HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
  1 recall0 reports
• HUDSON RCI IPN046880

  HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
  1 recall0 reports
• HUDSON RCI IPN913731

  Humidifier nebulizer kit
  1 recall0 reports
• HUDSON RCI IPN044731

  Tube, tracheal (w/wo connector)
  42 reports
• HUDSON RCI IPN049000

  TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
  40 reports
• HUDSON RCI IPN048896

  Tube, tracheal (w/wo connector)
  2 deaths32 reports
• HUDSON RCI IPN044767

  Tube, tracheal (w/wo connector)
  31 reports
• HUDSON RCI IPN044855

  TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
  31 reports
• HUDSON RCI IPN044856

  TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
  30 reports
• HUDSON RCI IPN048895

  Tube, tracheal (w/wo connector)
  1 death27 reports
• HUDSON RCI IPN046756

  Tube, tracheal (w/wo connector)
  25 reports
• HUDSON RCI IPN048873

  Tube, tracheal (w/wo connector)
  25 reports
• HUDSON RCI IPN044732

  Tube, tracheal (w/wo connector)
  21 reports
• HUDSON RCI IPN044730

  Tube, tracheal (w/wo connector)
  20 reports
• HUDSON RCI IPN048874

  Tube, tracheal (w/wo connector)
  20 reports
• HUDSON RCI IPN046759

  Tube, tracheal (w/wo connector)
  19 reports
• HUDSON RCI IPN048959

  Tube, tracheal (w/wo connector)
  18 reports
• HUDSON RCI IPN044768

  Tube, tracheal (w/wo connector)
  17 reports
• HUDSON RCI IPN048997

  TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
  16 reports
• HUDSON RCI IPN048897

  Tube, tracheal (w/wo connector)
  15 reports
• HUDSON RCI IPN044800

  Tube, tracheal (w/wo connector)
  13 reports
• HUDSON RCI IPN044728

  Tube, tracheal (w/wo connector)
  12 reports
• HUDSON RCI IPN040620

  NEBULIZER (DIRECT PATIENT INTERFACE)
  12 reports
• HUDSON RCI IPN040673

  CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
  11 reports
• HUDSON RCI IPN044799

  Tube, tracheal (w/wo connector)
  11 reports
• HUDSON RCI IPN049847

  Endoscopic bite block
  11 reports
• HUDSON RCI IPN044861

  TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
  10 reports
• HUDSON RCI IPN046758

  Tube, tracheal (w/wo connector)
  10 reports
• HUDSON RCI IPN046760

  Tube, tracheal (w/wo connector)
  1 death10 reports
• HUDSON RCI IPN048872

  Tube, tracheal (w/wo connector)
  1 death10 reports
• HUDSON RCI IPN048998

  TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
  9 reports
• HUDSON RCI IPN913687

  Circuit, breathing (w connector, adaptor, y piece)
  9 reports
• HUDSON RCI IPN044766

  Tube, tracheal (w/wo connector)
  8 reports
• HUDSON RCI IPN044386

  CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
  7 reports
• HUDSON RCI IPN044860

  TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
  7 reports
• HUDSON RCI IPN049001

  TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
  7 reports
• HUDSON RCI IPN044722

  Tube, tracheal (w/wo connector)
  6 reports
• HUDSON RCI IPN044723

  Tube, tracheal (w/wo connector)
  6 reports
• HUDSON RCI IPN049808

  NEBULIZER (DIRECT PATIENT INTERFACE)
  6 reports
• HUDSON RCI IPN914324

  DEVICE, FIXATION, TRACHEAL TUBE
  6 reports
• HUDSON RCI IPN913836

  Humidifier nebulizer kit
  6 reports
• HUDSON RCI IPN913839

  Humidifier nebulizer kit
  6 reports
• HUDSON RCI IPN913843

  Humidifier nebulizer kit
  6 reports
• HUDSON RCI IPN044418

  CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
  5 reports
• HUDSON RCI IPN044790

  Tube, tracheal (w/wo connector)
  5 reports
• HUDSON RCI IPN044906

  Tube, tracheal (w/wo connector)
  5 reports
• HUDSON RCI IPN046956

  CANNULA, NASAL, OXYGEN
  5 reports
• HUDSON RCI IPN048902

  Tube, tracheal (w/wo connector)
  5 reports
• HUDSON RCI IPN914325

  DEVICE, FIXATION, TRACHEAL TUBE
  1 death5 reports
• HUDSON RCI IPN044847

  STYLET, TRACHEAL TUBE
  4 reports
• HUDSON RCI IPN048866

  Tube, tracheal (w/wo connector)
  4 reports
• HUDSON RCI IPN048875

  Tube, tracheal (w/wo connector)
  4 reports
• HUDSON RCI IPN048992

  STYLET, TRACHEAL TUBE
  4 reports
• HUDSON RCI IPN049872

  Circuit, breathing (w connector, adaptor, y piece)
  4 reports
• HUDSON RCI IPN913684

  Circuit, breathing (w connector, adaptor, y piece)
  4 reports
• HUDSON RCI IPN913861

  HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
  4 reports
• HUDSON RCI IPN039351

  Ventilator, emergency, manual (resuscitator)
  4 reports
• HUDSON RCI IPN044726

  Tube, tracheal (w/wo connector)
  3 reports
• HUDSON RCI IPN044729

  Tube, tracheal (w/wo connector)
  3 reports
• HUDSON RCI IPN044733

  Tube, tracheal (w/wo connector)
  3 reports
• HUDSON RCI IPN044900

  Tube, tracheal (w/wo connector)
  3 reports
• HUDSON RCI IPN046757

  Tube, tracheal (w/wo connector)
  3 reports
• HUDSON RCI IPN048871

  Tube, tracheal (w/wo connector)
  3 reports
• HUDSON RCI IPN048894

  Tube, tracheal (w/wo connector)
  3 reports
• HUDSON RCI IPN048951

  Tube, tracheal (w/wo connector)
  3 reports
• HUDSON RCI IPN049141

  SPIROMETER, THERAPEUTIC (INCENTIVE)
  3 reports
• HUDSON RCI IPN049298

  NEBULIZER (DIRECT PATIENT INTERFACE)
  3 reports
• HUDSON RCI IPN049300

  NEBULIZER (DIRECT PATIENT INTERFACE)
  3 reports
• HUDSON RCI IPN049316

  SPIROMETER, THERAPEUTIC (INCENTIVE)
  3 reports
• HUDSON RCI IPN913994

  HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
  3 reports
• HUDSON RCI IPN044727

  Tube, tracheal (w/wo connector)
  2 reports
• HUDSON RCI IPN044769

  Tube, tracheal (w/wo connector)
  2 reports
• HUDSON RCI IPN042652

  Filter, bacterial, breathing-circuit
  2 reports
• HUDSON RCI IPN048865

  Tube, tracheal (w/wo connector)
  1 death2 reports
• HUDSON RCI IPN048904

  Tube, tracheal (w/wo connector)
  2 reports
• HUDSON RCI IPN048960

  Tube, tracheal (w/wo connector)
  2 reports
• HUDSON RCI IPN049002

  TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
  2 reports
• HUDSON RCI IPN049742

  CANNULA, NASAL, OXYGEN
  2 reports
• HUDSON RCI IPN049113

  Humidifier nebulizer kit
  2 reports
• HUDSON RCI IPN049284

  NEBULIZER (DIRECT PATIENT INTERFACE)
  2 reports
• HUDSON RCI IPN049200

  NEBULIZER (DIRECT PATIENT INTERFACE)
  2 reports
• HUDSON RCI IPN049908

  Circuit, breathing (w connector, adaptor, y piece)
  2 reports
• HUDSON RCI IPN913814

  Humidifier nebulizer kit
  2 reports
• HUDSON RCI IPN049845

  HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
  2 reports
• HUDSON RCI IPN916682

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  2 reports
• HUDSON RCI IPN044724

  Tube, tracheal (w/wo connector)
  1 report
• HUDSON RCI IPN044735

  Tube, tracheal (w/wo connector)
  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.

• OtherSep 29, 2026Fluid/Blood Leak

  It was reported that during use in the neonatal intensive care unit, a large amount of fluid accumulated inside the HUDSON RCI brand heated breathing circuit set.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933217 ↗
• MalfunctionSep 28, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917231 ↗
• MalfunctionSep 23, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870974 ↗
• MalfunctionSep 23, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870723 ↗
• MalfunctionSep 8, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674835 ↗
• MalfunctionAug 27, 2026Decoupling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50477647 ↗
• MalfunctionAug 7, 2026Defective Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181590 ↗
• MalfunctionJul 31, 2026Decoupling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50101963 ↗
• MalfunctionJul 9, 2026Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON A PATIENT. CHANGE TO A NEW TUBE." NO PATIENT INJURY OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25769479 ↗
• MalfunctionJul 6, 2026Gas/Air Leak

  IT WAS REPORTED THAT "ETT CUFF WOULD NOT HOLD PRESSURE AFTER PLACEMENT. SOMETIMES THE LEAK WAS OBVIOUS (CUFF DEFLATED QUICKLY), WHILE OTHER TIMES IT WAS A SLOW LEAK OVER TIME. IN ALL OF THESE CASES, THE PATIENT ULTIMATELY REQUIRED AN ETT EXCHANGE. THE CUFFS ARE ROUTINELY TESTED BEFORE INTUBATION AND APPEAR TO BE FUNCTIONING PROPERLY AT THE TIME OF PLACEMENT, BUT IT'S DIFFICULT TO IDENTIFY A SLOW LEAK IN THE MOMENTS PRIOR TO INTUBATION. OVER THE PAST 9 MONTHS, THERE HAVE BEEN 6 INCIDENTS WHERE A TUBE HAD A SLOW LEAK WHILE IN THE PATIENT. IN ONE INCIDENT, THE TUBE COMPLETELY BURST AND FAILED. THERE WAS PATIENT INVOLVEMENT AND NO HARM." TWO ISSUES REPORTED (CUFF LEAK AND BURST). ASSOCIATED MDRS: 3003898360-2026-00290. ADDITIONAL INFORMATION RECEIVED ON JUNE 16, 2026, INDICATED THAT THERE WERE NO REPORTS OF PATIENT HARM OR ADVERSE HEALTH CONSEQUENCES. HOWEVER, PATIENTS REQUIRED REINTUBATION IN THE REPORTED EVENTS. NO INFORMATION IS AVAILABLE REGARDING THE INDIVIDUAL PATIENTS' CURRENT CONDITION. THE TIME THE TUBES REMAINED IN PLACE BEFORE THE ISSUE WAS DETECTED VARIED FROM MINUTES TO HOURS. SOME PATIENTS EXPERIENCED DESATURATION, WITH VARYING DEGREES OF SEVERITY. THE DEVICES WERE TESTED

  Patient problems: Low Oxygen Saturation

  MAUDE report 25727770 ↗
• MalfunctionMay 25, 2026Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING IT ON THE PATIENT. THE TUBE WAS REPLACED." NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273323 ↗
• MalfunctionMay 25, 2026Decoupling

  IT WAS REPORTED THAT "CUSTOMER STATES THE ETT HAD ISSUES WITH THE PLASTIC CONNECTOR DISCONNECTING FROM CIRCUIT 5 MINUTES AFTER INTUBATION. THE RESPIRATORY THERAPIST USED ANOTHER CONNECTOR. THERAPY WAS NOT DELAYED, AND THE PATIENT IS FINE AND DID NOT DESATURATE." NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE RESPIRATORY THERAPIST USED ANOTHER CONNECTOR FROM A DIFFERENT ETT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25272644 ↗
• MalfunctionMay 21, 2026Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE NEW TUBE." NO PATIENT INJURY OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25245429 ↗
• MalfunctionMay 14, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT "THE RT'S NOTICED THE DEPTH MARKINGS ARE UP TO 0.5CM OFF MEASUREMENT." ADDITIONAL INFORMATION RECEIVED ON APRIL 20, 2026, INDICATED THAT "NO PATIENT INJURY OR CONSEQUENCE REPORTED, NO MEDICAL INTERVENTION REQUIRED. THE PATIENT STATUS IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178524 ↗
• MalfunctionMay 12, 2026Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE NEW TUBE." NO PATIENT INJURY OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25156508 ↗

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