HUDSON RCI HUD88015KITRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10197344010479), received between Nov 17, 2025 and Jun 4, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Melted” (6 reports).

1 FDA recall record name this device's 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, 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 18, 2026.

Recalls naming this device

1. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Overheating of Device

  IT WAS REPORTED THAT THE CONNECTION POINT WHERE THE CIRCUIT CONNECTS TO THE HEATER IS BURNED AND MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25393899 ↗
• MalfunctionJun 4, 2026Overheating of Device

  IT WAS REPORTED THAT THE CONNECTION POINT WHERE THE CIRCUIT CONNECTS TO THE HEATER WAS BURNED AND MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25393713 ↗
• MalfunctionJun 4, 2026Overheating of Device

  IT WAS REPORTED THAT THE CONNECTION POINT WHERE THE CIRCUIT CONNECTS TO THE HEATER WAS BURNED AND MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392066 ↗
• MalfunctionJun 4, 2026Overheating of Device

  IT WAS REPORTED THAT THE CONNECTION POINT WHERE THE CIRCUIT CONNECTS TO THE HEATER WAS BURNED AND MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25391746 ↗
• MalfunctionMay 21, 2026Thermal Decomposition of Device; Temperature Problem

  IT WAS REPORTED THAT IT WAS BECOMING HOT, MELTING AND REQUIRING THE CIRCUIT TO BE CHANGED.

  Patient problems: Insufficient Information

  MAUDE report 25249497 ↗
• MalfunctionMay 21, 2026Thermal Decomposition of Device; Temperature Problem

  IT WAS REPORTED THAT ISO-SHIELD BREATHING CIRCUITS BECOMING HOT, MELTING AND REQUIRING THE CIRCUIT TO BE CHANGED.

  Patient problems: Insufficient Information

  MAUDE report 25247916 ↗
• MalfunctionMay 19, 2026Overheating of Device

  IT WAS REPORTED THAT BREATHING CIRCUITS BECOMING HOT, MELTING AND REQUIRING THE CIRCUIT TO BE CHANGED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25221396 ↗
• MalfunctionMay 19, 2026Thermal Decomposition of Device; Temperature Problem

  IT WAS REPORTED THAT BREATHING CIRCUIT WERE BECOMING HOT, MELTING, AND REQUIRING CIRCUIT TO BE CHANGED.

  Patient problems: Insufficient Information

  MAUDE report 25221347 ↗
• MalfunctionMay 1, 2026Material Discolored; Melted

  ACCORDING TO THE FACILITY, ON (B)(6) 2026, THE CIRCUITS WERE BEING USED ON NEONATAL PATIENTS REQUIRING RESPIRATORY SUPPORT IN CRITICAL CARE, INCLUDING INTUBATION AND NONINVASIVE POSITIVE PRESSURE VENTILATION. THE HEATER PORTION BEGAN ALARMING "LOW TEMP" AND UPON INVESTIGATION, THE CIRCUITS WERE FOUND MELTED AND TURNING BLACK AT THE CONNECTION FEEDING TO THE HEATER. THE HEATER WAS TURNED OFF, UNPLUGGED, AND THE CIRCUIT WAS REMOVED AND REPLACED. THE FACILITY REPORTS NO MEDICAL INTERVENTION OR TREATMENT REQUIRED FOR THE PATIENTS, THEY ARE IN "STABLE CONDITION." NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25060148 ↗
• MalfunctionMay 1, 2026Material Discolored; Melted; Material Deformation

  ACCORDING TO THE FACILITY, ON (B)(6) 2026, THE CIRCUITS WERE BEING USED ON NEONATAL PATIENTS REQUIRING RESPIRATORY SUPPORT IN CRITICAL CARE, INCLUDING INTUBATION AND NONINVASIVE POSITIVE PRESSURE VENTILATION. THE HEATER PORTION BEGAN ALARMING "LOW TEMP" AND UPON INVESTIGATION, THE CIRCUITS WERE FOUND MELTED AND TURNING BLACK AT THE CONNECTION FEEDING TO THE HEATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059990 ↗
• MalfunctionMay 1, 2026Material Discolored; Melted; Material Deformation

  ACCORDING TO THE FACILITY, ON (B)(6) 2026, THE CIRCUITS WERE BEING USED ON NEONATAL PATIENTS REQUIRING RESPIRATORY SUPPORT IN CRITICAL CARE, INCLUDING INTUBATION AND NONINVASIVE POSITIVE PRESSURE VENTILATION. THE HEATER PORTION BEGAN ALARMING "LOW TEMP" AND UPON INVESTIGATION, THE CIRCUITS WERE FOUND MELTED AND TURNING BLACK AT THE CONNECTION FEEDING TO THE HEATER. THE HEATER WAS TURNED OFF, UNPLUGGED, AND THE CIRCUIT WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057434 ↗
• MalfunctionApr 30, 2026Circuit Failure

  PER REPORT, THERE WERE MULTIPLE FAILURE EVENTS AT (B)(6) HOSPITAL / PMC INVOLVING MEDLINE KIT NEONATAL ISO GUARD BREATHING CIRCUIT: HUD88015KIT, LOT # 25DOA334.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25047545 ↗
• MalfunctionApr 29, 2026Melted

  ACCORDING TO THE FACILITY, THE CIRCUITS WERE BEING USED ON NEONATAL PATIENTS REQUIRING RESPIRATORY SUPPORT IN CRITICAL CARE, INCLUDING INTUBATION AND NONINVASIVE POSITIVE PRESSURE VENTILATION. THE HEATER PORTION BEGAN ALARMING "LOW TEMP" AND UPON INVESTIGATION, THE CIRCUITS WERE FOUND MELTED AND TURNING BLACK AT THE CONNECTION FEEDING TO THE HEATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034134 ↗
• MalfunctionApr 17, 2026Material Discolored; Melted; Material Deformation

  ACCORDING TO THE FACILITY, ON (B)(6) 2026, THE CIRCUITS WERE BEING USED ON NEONATAL PATIENTS REQUIRING RESPIRATORY SUPPORT IN CRITICAL CARE, INCLUDING INTUBATION AND NONINVASIVE POSITIVE PRESSURE VENTILATION. THE HEATER PORTION BEGAN ALARMING "LOW TEMP" AND UPON INVESTIGATION, THE CIRCUITS WERE FOUND MELTED AND TURNING BLACK AT THE CONNECTION FEEDING TO THE HEATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913793 ↗
• MalfunctionNov 17, 2025Melted; Melted

  CIRCUIT MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23574480 ↗