MEDLINE MDS149000Recalls & reported problems
Medline Industries, Inc. · PACK,HOT,INSTANT,DLX,NONWOVEN,6"" X 8"" · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00080196749891), received between Oct 29, 2020 and Jun 5, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
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
- Burst Container or Vessel1
- Fire1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2026No Apparent Adverse Event
CUSTOMER STATED THAT THEY "WENT TO ACTIVATE A NEW HOT PACK OVER PATIENT BED AND HOT PACK EXPLODED ALL OVER THE PATIENT'S FACE AND TORSO".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25416541 ↗MalfunctionMay 20, 2026Burst Container or Vessel
IT WAS REPORTED THAT "WHILE ACTIVATING THE HOT PACK, THE HOT PACK EXPLODED IN STAFF'S HAND , COVERING FINGERS WITH INTERNAL CONTENTS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25229108 ↗MalfunctionOct 29, 2020Fire
IT WAS REPORTED A FIRE WAS SUSPECTED OF RESULTING FROM AN INSTANT HOT PACK BEING DISPOSED OF IN THE SAME TRASH BAG AS SEVERAL ALCOHOL PREP PADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10757137 ↗
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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