Medline MDS139009Recalls & reported problems
Medline Industries, Inc. · PACK,HOT,INSTANT,LRG,6X9" · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10888277320550), received between May 21, 2018 and Sep 25, 2026 — classified as 3 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
- Adverse Event Without Identified Device or Use Problem1
- Burst Container or Vessel1
- Explosion1
- Improper or Incorrect Procedure or Method1
- Insufficient Device Problem Information1
- Material Integrity Problem1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Chemical Exposure2
- Burn(s)1
- Burning Sensation1
- Eye Injury1
- Skin Inflammation/ Irritation1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Leak/Splash
It was reported that a hot pack containing Sodium Acetate ruptured during use, resulting in a crystallized substance found on the patient's forearm following a peripheral IV insertion.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902356 ↗MalfunctionSep 7, 2026Premature Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50650951 ↗MalfunctionAug 13, 2026Leak/Splash
It was reported that "THE CUOLD PACK RUPTURED DURING NORMAL SQUEEZING FOR ACTIVATION FOR PATIENT CARE AND CONTENTS LEAKED OUT ONTO THE MEDICAL ASSISTANTS CLOTHING.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230413 ↗MalfunctionJul 3, 2026Explosion
IT WAS REPORTED THAT THE COLD PACK BURST INTO THE HANDS OF A PROVIDER WHILE SHE WAS ATTEMPTING TO ACTIVATE THE COLD PACK.
Patient problems: Burning Sensation; Skin Inflammation/ Irritation
MAUDE report 25703346 ↗MalfunctionMay 27, 2026No Apparent Adverse Event
CUSTOMER STATED "THE INSTANT HOT PACKS THAT STARTED LEAKING AT SOON AS THEY WERE ACTIVATED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25311052 ↗InjuryJan 8, 2026Insufficient Device Problem Information
InjuryFeb 20, 2023Burst Container or Vessel; Material Integrity Problem; Burst Container or Vessel; Material Integrity Problem
ACCORDING TO THE FACILITY A HOT PACK EXPLODED IN THE NURSE'S EYES AND FACE WHEN ATTEMPTING TO ACTIVATE IT.
Patient problems: Chemical Exposure
MAUDE report 16403940 ↗MalfunctionNov 4, 2020Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A HOT PACK BURNED A PATIENT'S RIGHT SCAPULA.
Patient problems: Superficial (First Degree) Burn
MAUDE report 10785862 ↗InjuryMay 21, 2018Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE EMPLOYEE "TWISTED THE BAG" TO ACTIVATE THE HOT PACK AND ITS CONTENTS CONTACTED THE EMPLOYEE'S RIGHT EYE.
Patient problems: Chemical Exposure; Eye Injury
MAUDE report 7529818 ↗
Other PACK, HOT OR COLD, DISPOSABLE devices
- ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & HipPfizer Inc. · PACK, HOT OR COLD, DISPOSABLE196 reports
- NOVAPLUS V11460-010Cardinal Health 200, LLC · PACK, HOT OR COLD, DISPOSABLE1 recall16 reports
- CARDINAL HEALTH 11443-012BCardinal Health 200, LLC · PACK, HOT OR COLD, DISPOSABLE56 reports
- ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & HipPfizer Inc. · PACK, HOT OR COLD, DISPOSABLE37 reports
- ThermaCare HeatWraps ThermaCare HeatWraps - Neck, Wrist & ShoulderPfizer Inc. · PACK, HOT OR COLD, DISPOSABLE1 death31 reports
- CARDINAL HEALTH 11450-040Cardinal Health 200, LLC · PACK, HOT OR COLD, DISPOSABLE20 reports
- ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & HipPfizer Inc. · PACK, HOT OR COLD, DISPOSABLE14 reports
- Medline MDS139008Medline Industries, Inc. · PACK, HOT OR COLD, DISPOSABLE13 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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