CARDINAL HEALTH 11460-010T (UDI 10192253061420)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10192253061420), received between Mar 21, 2023 and Jul 6, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (15 reports).

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.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026

  FROM STAFF: HEEL WARMER WAS ALREADY ACTIVATED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25716745 ↗
• MalfunctionJun 1, 2026

  FROM STAFF: HEEL WARMER DID NOT GET WARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25347366 ↗
• MalfunctionApr 16, 2026

  FROM STAFF: INFANT HEEL WARMERS ARE BEING SQUEEZED TO WARM UP AND ARE STAYING COLD AND NOT WARMING AT ALL. WE HAVE HAD 4-5 THAT HAVE REMAINED COLD. REF#11460-010T.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895094 ↗
• MalfunctionMay 3, 2024

  EMPLOYEE ¿CRACKED¿ THE HEEL WARMER, PER INSTRUCTIONS. THE HEEL WARMERS CONTENTS EXPLODED OUT OF THE TOP AND LANDED ON EMPLOYEE. THIS INCLUDED THE CONTENT GETTING INTO HER RIGHT EYE. THE EMPLOYEE WAS SEEN BY EMPLOYEE HEALTH AND CLEARED TO RETURN TO WORK.

  Patient problems: Chemical Exposure

  MAUDE report 19237202 ↗
• MalfunctionAug 23, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT ¿¿IN THE NICU, THIS PRODUCT IS EXPLODING WHEN ACTIVATED. IT EXPLODED ONTO SEVERAL STAFF MEMBERS, POTENTIALLY CAUSING HARM TO A FEW. THE PACK CONTENTS CAME IN CONTACT THE RN¿S NOSE AND MUCOUS MEMBRANES. NOSE WAS RINSED. I HAVE SOME OF THE EXPLODED PRODUCT IN MY OFFICE. WE HAVE REMOVED THE LOT NUMBER FROM THE FLOORS AND PATIENT ROOMS. ALL STAFF MEMBERS APPEAR TO BE DOING FINE. NO RESIDUAL COMPLAINTS NOTED.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17605315 ↗
• MalfunctionAug 23, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT ¿IN THE NICU, THIS PRODUCT IS EXPLODING WHEN ACTIVATED. IT EXPLODED ONTO SEVERAL STAFF MEMBERS, POTENTIALLY CAUSING HARM TO A FEW. THE PACK CONTENTS CAME IN CONTACT WITH RN¿S EYES. I HAVE SOME OF THE EXPLODED PRODUCT IN MY OFFICE. WE HAVE REMOVED THE LOT NUMBER FROM THE FLOORS AND PATIENT ROOMS. A PROVIDER ON OUR UNIT INSPECTED HER EYES. EYE WASH DONE. ALL STAFF MEMBERS APPEAR TO BE DOING FINE. NO RESIDUAL COMPLAINTS NOTED¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17604324 ↗
• MalfunctionAug 15, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THEY HAD TWO MORE HEEL WARMERS/HEAT PACKS BURST. NO PATIENTS OR EMPLOYEES WERE INJURED OR SPRAYED WITH THE INTERNAL CONTENTS OF THE HEAT PACK. AFTER THE INCIDENT, THE STAFF WENT THROUGH ALL OF THE WARMERS AND FOUND MORE PACKS WITH OPEN OUTER SEAMS AND PULLED THEM OUT OF SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552982 ↗
• MalfunctionAug 15, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT THEY HAD TWO MORE HEEL WARMERS/HEAT PACKS BURST. NO PATIENTS OR EMPLOYEES WERE INJURED OR SPRAYED WITH THE INTERNAL CONTENTS OF THE HEAT PACK. AFTER THE INCIDENT, THE STAFF WENT THROUGH ALL OF THE WARMERS AND FOUND MORE PACKS WITH OPEN OUTER SEAMS AND PULLED THEM OUT OF SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552946 ↗
• MalfunctionAug 2, 2023Burst Container or Vessel; Burst Container or Vessel

  MW2000330000-2023-8030: EMPLOYEE WENT TO GET HEEL WARMER INITIATED WHERE IT BURST AND SQUIRT EMPLOYEE IN THE FACE, ALL OVER CHEST AND ABDOMEN WITH HARMFUL MATERIAL. THERE WAS NO INJURY OR MEDICAL CARE REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17443009 ↗
• MalfunctionJul 13, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED HEEL WARMER EXPLODED IN ANOTHER NURSE¿S FACE. THERE WAS NO INJURY. NO FURTHER INFORMATION WAS PROVIDED WHEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321832 ↗
• MalfunctionJul 10, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT SOME HEEL WARMERS ARE SPONTANEOUSLY POPPING WHEN ACTIVATING ON THE NICU FLOOR ON HANDS AND CLOTHING OF NURSES. NO INJURY OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED WHEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17294388 ↗
• MalfunctionMay 5, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED, WHEN THE INFANT HEEL WARMER WAS SQUEEZED TO ACTIVATE. THE CONTENTS OF THE PACKET CAME OUT OF THE TOP, AND LANDED ON ONE OF THE PATIENTS. THIS HAS HAPPENED TWICE NOW. THE EVENT DATE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882674 ↗
• MalfunctionMay 5, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED, WHEN THE INFANT HEEL WARMER WAS SQUEEZED TO ACTIVATE. THE CONTENTS OF THE PACKET CAME OUT OF THE TOP, AND LANDED ON ONE OF THE STAFF MEMBERS. THIS HAS HAPPENED TWICE NOW. THE EVENT DATE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882663 ↗
• MalfunctionMay 5, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED WHEN THE INFANT HEEL WARMER WAS SQUEEZED TO ACTIVATE, THE CONTENTS OF THE PACKET CAME OUT OF THE TOP AND LANDED ON ONE OF THE PATIENTS. THIS HAS HAPPENED TWICE NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882267 ↗
• MalfunctionMay 5, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED WHEN THE INFANT HEEL WARMER WAS SQUEEZED TO ACTIVATE, THE CONTENTS OF THE PACKET CAME OUT OF THE TOP AND LANDED ON ONE OF THE STAFF MEMBERS. THIS HAS HAPPENED TWICE NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882257 ↗
• MalfunctionMay 1, 2023Burst Container or Vessel; Burst Container or Vessel

  CARDINAL HEALTH INFANT HEEL WARMER, BURST WHILE NURSE WAS ACTIVATING. SHE DID NOT SEEK ANY MEDICAL CARE AS SHE STATES THE CONTENTS OF THE HEEL WARMER LANDED MAINLY ON HER CHEST, DOWN HER UNIFORM AND ON HER PANTS. SHE WAS WEARING GLOVES AND CONTENTS DID NOT MAKE CONTACT WITH SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845267 ↗
• MalfunctionMar 28, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED THAT WHEN ONE OF THE NURSES WAS DOING A LAB TONIGHT, THEY SQUEEZED THE HEEL WARMER TO ACTIVATE IT AND THE WHOLE HEEL WARMER BUSTED OPEN ONTO THE BACK OF THE SHIRT OF THE PATIENT¿S FATHER. THERE WAS NO ADVERSE EVENT OR INJURY. THE ACTUAL EVENT DATE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632365 ↗
• MalfunctionMar 21, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED ¿THE INFANT HEEL WARMER POPPED RECENTLY, BURSTING ON THE NURSE'S INTACT SKIN OF HANDS AND ON FLOOR. THERE WAS NO INJURY AND THE NURSE IS FINE¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587713 ↗
• MalfunctionMar 21, 2023Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTED ¿THE INFANT HEEL WARMER POPPED RECENTLY, BURSTING ON THE NURSE'S INTACT SKIN OF HANDS AND ON FLOOR. THERE WAS NO INJURY AND THE NURSE IS FINE¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587617 ↗