Medline MDS139008Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10888277320543), received between Jan 30, 2020 and Sep 9, 2026 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Powder Leak

  Patient problems: Burn(s)

  MAUDE report 50696511 ↗
• MalfunctionSep 8, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675066 ↗
• MalfunctionJul 10, 2026Explosion

  IT WAS REPORTED THAT THE "ONE OF THE MEDLINE WARM PACKS "EXPLODED" WHEN IT WAS GOING TO BE ACTIVATED AND SPLASHED THE PATIENT IN THE FACE AND GETTING INTO THEIR EYES REQUIRING EYE WASHOUT AND AN OPHTHALMOLOGY CONSULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25785189 ↗
• MalfunctionDec 3, 2025Material Rupture; Material Rupture

  ACCORDING TO THE FACILITY, A PATIENT REQUESTED A HEAT PACK. WHILE ATTEMPTING TO ACTIVATE, ONE PACKAGE RUPTURED, SPILLING POWDER ON THE PATIENT. THE PATIENT HAD IRRITATION TO THE CHEST, ABDOMEN, AND HAND.

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 23711207 ↗
• MalfunctionFeb 28, 2024

  INSTANT HOT PACK USED ON BILATERAL GROINS AND AXILLA. AFTER APPROXIMATELY 20 MINUTES, REDNESS AND BLISTERING NOTED TO RIGHT GROIN. MANUFACTURER RESPONSE FOR PACK, HOT OR COLD, DISPOSABLE, MEDLINE (PER SITE REPORTER). CENTRAL SUPPLY HAS DISCLOSED TO MANUFACTURER.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18796164 ↗
• MalfunctionFeb 28, 2024

  INSTANT HOT PACK PLACED TO LEFT FOREARM, BLISTERS NOTED BY STAFF UPON REMOVAL. MANUFACTURER RESPONSE FOR PACK, HOT OR COLD, DISPOSABLE, MEDLINE (PER SITE REPORTER). CENTRAL SUPPLY HAS NOTIFIED MANUFACTURER.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18796137 ↗
• InjuryJan 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2022 WHEN USING THE HOT PACK THE 'RN ACTIVATED HEAT PACK AND CONTENTS SHOT OUT OF THE TOP AND WENT INTO PATIENT'S EYE'.

  Patient problems: Foreign Body Sensation in Eye

  MAUDE report 16148093 ↗
• InjuryDec 29, 2022Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE FACILITY ON 12/13/22 A STAFF MEMBER "SQUEEZED THE HOT PACK TO BREAK THE SEAL AND IT EXPLODED GETTING CHEMICALS IN THEIR RIGHT EYE".

  Patient problems: Chemical Exposure

  MAUDE report 16075190 ↗
• InjuryNov 2, 2022Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE FACILITY ON (B)(4) 2022 A HOT PACK WAS BROUGHT INTO THE PATIENT ROOM AND WHEN THE STAFF MEMBER ATTEMPTED TO ACTIVATE THE PACK, 'THE PACK EXPLODED FROM THE TOP SEAM,' AND GOT INTO THE STAFF MEMBERS EYES.

  Patient problems: Chemical Exposure

  MAUDE report 15716163 ↗
• MalfunctionDec 24, 2020Burst Container or Vessel

  IT WAS REPORTED THAT DURING ACTIVATION, A HOT PACK EXPLODED IN THE FACE OF THE END-USER.

  Patient problems: Insufficient Information

  MAUDE report 11071905 ↗
• InjuryNov 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING ACTIVATION, A HOT PACK EXPLODED IN THE END-USERS EYE WHEN SHE SQUEEZED THE BAG TO ACTIVATE IT.

  Patient problems: Foreign Body Sensation in Eye

  MAUDE report 10896747 ↗
• MalfunctionOct 28, 2020Leak/Splash; Material Split, Cut or Torn

  RN POPPED HOT PACK TO APPLY TO FOREARM TO PREPARE VEIN AND HOT PACK OPENED UP AND SPILT ON PATIENT. PATIENT WAS NOT INJURED IN EVENT.

  Patient problems: Chemical Exposure

  MAUDE report 10746990 ↗
• MalfunctionJan 30, 2020Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE STAFF MEMBER ACTIVATED THE HOT PACK BY "PUNCHING" THE PRODUCT AGAINST A COUNTER.

  Patient problems: No Code Available

  MAUDE report 9649824 ↗