MEDLINE MDS138007Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10080196719655), received between Feb 24, 2016 and Sep 30, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Insufficient Heating” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Insufficient Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951861 ↗
• MalfunctionSep 30, 2026Insufficient Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948659 ↗
• MalfunctionSep 30, 2026Leak/Splash

  It was reported that the heel warmer ruptured during removal from a patient, causing the fluid inside to splash onto the reporter's face and the patient's leg.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947932 ↗
• MalfunctionSep 28, 2026Insufficient Heating

  It was reported that "MEDLINE INFANT HEEL WARMERS (9.5CM X 14CM) X2 GOT COLD INSTEAD OF HOT WHEN ACTIVATED PER INSTRUCTIONS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913183 ↗
• MalfunctionSep 9, 2026Fluid/Blood Leak; Premature Activation; Sharp Edges

  It was reported that "It appears as something from the inside punctured through when the nurse was kneading the pack." "Pouch appeared to have a tiny pin prick in the bag upon inspection following the injury.".

  Patient problems: Needle Stick/Puncture

  MAUDE report 50695652 ↗
• MalfunctionSep 9, 2026Gel Leak

  It was reported that "she went to break the packet so it would heat up and it \"exploded all over a nurse colleague\" of hers."

  Patient problems: Paresthesia

  MAUDE report 50691033 ↗
• MalfunctionSep 8, 2026Insufficient Heating

  It was reported that 2 Infant Heel Warmers cracked and felt cold.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50667553 ↗
• MalfunctionAug 7, 2026Insufficient Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176016 ↗
• InjuryAug 14, 2025Material Rupture; Material Rupture

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, A HEEL WARMER APPEARED TO HAVE LEAKED ONTO INFANT'S RIGHT HEEL. THE CUSTOMER STATED THAT UPON FURTHER ASSESSMENT, THE HEEL "APPEARED TO BE RED, PAINFUL TO TOUCH, SLOUGHING SKIN AND WEEPY.".

  Patient problems: Burn(s)

  MAUDE report 22809547 ↗
• InjuryFeb 24, 2016Leak/Splash; Therapeutic or Diagnostic Output Failure

  INFANT HEEL WARMER WAS APPLIED TO HEEL AFTER ACTIVATION OF WARMER PACKAGE. PACKAGE REMAINED ON BABY'S HEEL FOR 7-10MIN AND WHEN REMOVED, THE SKIN FROM HEEL WAS REMOVED AS WELL. ADDITIONALLY, THE GREAT TOE AREAS ON PLANTAR SURFACE ALSO HAD DEVELOPED INTO FLUID BLISTER, THAT REMAINED INTACT. NURSING STATES THE PACKAGE WAS DISCOVERED TO HAVE A SMALL LEAK ON THE INNER SEAM OF THE PACKAGE. NURSING NOTED THAT ALL CONTENTS OF THE PACKAGE WERE EMPTIED OUT, AS THE SUBSTANCE HAD POOLED AT THE BOTTOM OF AREA WHERE IT WAS APPLIED. DOSE OR AMOUNT: ONE EACH. FREQUENCY: AS NEEDED FOR LABS. ROUTE TRANSDERMAL. DIAGNOSIS OR REASON FOR USE: TO PROMOTE CIRCULATION OF BLOOD FOR LAB DRAW.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 5462958 ↗