MEDLINE MDS138000Recalls & reported problems
Medline Industries, Inc. · PACK,COLD,INSTANT,HEAVY-WEIGHT, 6X10 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10080196158522), received between Mar 11, 2019 and Sep 29, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 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/Splash4
- Break1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Chemical Exposure1
- Eye Injury1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: Chemical Exposure
MAUDE report 50933121 ↗MalfunctionAug 10, 2026Leak/Splash
It was reported that the cold pack leaked on the customers sheets onto her pads that she was laying on. Customer informed the cold pack exploded but customer was unable to find a leak.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50195858 ↗MalfunctionJul 27, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50000469 ↗MalfunctionMay 5, 2026Break
CUSTOMER REPORTED, "WHEN ICE PACK FOLDED TO ACTIVATE, PRODUCT LEAKED OUT FROM THE END/BUSTED OPEN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25089751 ↗MalfunctionNov 27, 2020Leak/Splash
IT WAS REPORTED, AN ACCU-THERM INSTANT HEAVY-WEIGHT JR. COLD PACK "HAD EXPLODE OPEN, AND WENT ALL OVER THE WALLS, CEILING, AND SPRAYED INTO THE EYES OF A NURSE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10914004 ↗MalfunctionMar 11, 2019Leak/Splash
IT WAS REPORTED THAT THE INSTANT COLD PACK CONTENTS/LIQUIDS LEAKED FROM THE PACK'S UPPER SEAM AND END-USER REQUIRED EYE IRRIGATION.
Patient problems: Eye Injury
MAUDE report 8409512 ↗
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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