Halyard 51775Recalls & reported problems
Owens & Minor Distribution, Inc. · INSTANT WARM PACK LARGE 6X9IN SODIUM ACETATE CA/24 SINGLE PT USE Not made with Natural Rubber Latex Halyard · Class 1
All models of Halyard (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885632413735), received between Jun 3, 2025 and Jun 3, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Explosion” (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
- Explosion2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Eye Burn1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 3, 2025Explosion; Explosion
THE NURSE REPORTED HEAT PACK EXPLODED OVER MOM AND BABY. SHE STATED THAT SHE WENT INTO THE ROOM AND IMMEDIATELY GRABBED THE BABY TO WASH HIM OFF BECAUSE HE WAS COVERED IN THE CONTENTS FROM THE HEAT PACK. THE PATIENT STATED SHE FELT LIKE HER FACE WAS BURNING AS THE CONTENTS GOT INTO HER LEFT EYE. THE NURSE IMMEDIATELY WASHED OUT THE MOM'S EYES. THE NURSE STATED SHE WANTED TO GET THE BABY CLEANED UP QUICKLY AND GET MOM ASSESSED BY HER OB DOCTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 22136584 ↗InjuryJun 3, 2025Explosion; Explosion
THE NURSE REPORTED HEAT PACK EXPLODED ALL OVER MOM AND BABY. SHE STATED THAT SHE WENT INTO THE ROOM AND IMMEDIATELY GRABBED THE BABY TO WASH HIM OFF BECAUSE HE WAS COVERED IN THE CONTENTS FROM THE HEAT PACK. THE PATIENT STATED SHE FELT LIKE HER FACE WAS BURNING AS THE CONTENTS GOT INTO HER LEFT EYE. THE NURSE IMMEDIATELY WASHED OUT THE MOM'S EYES. THE NURSE STATED SHE WANTED TO GET THE BABY CLEANED UP QUICKLY AND HAVE MOM ASSESSED BY HER OB DOCTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.
Patient problems: Eye Burn
MAUDE report 22136583 ↗
Other PACK, HOT OR COLD, DISPOSABLE devices
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- 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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