CURAD CURFAK300RBV1Recalls & reported problems
Medline Industries, Inc. · FAK,COMPLETE,CURAD,175PC/KIT,6KIT/CS · Class N
All models of CURAD (85)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00193489100351), received between Sep 14, 2026 and Sep 24, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Biocompatibility” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Biocompatibility1
- Break1
- Explosion1
- Material Puncture/Hole1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Erythema1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890103 ↗MalfunctionSep 24, 2026Break
It was reported that "COLD PACK IN FIRST AID KIT CURFAK300RV1H WAS BROKEN ON ARRIVAL. MB SAYS SOME ITEMS IN THE FIRST AID KIT GOT WET."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889325 ↗MalfunctionSep 24, 2026Biocompatibility
It was reported that "The thin white surgical tape in that kit has left a burn-like mark in the shape of the tape in 4 areas on my upper left chest area, one very long strip mark is still there after 1 week of removal and 3 smaller red marks. The tape was only on the area for one night and removed the next morning (less than 9 hours)."
Patient problems: Erythema
MAUDE report 50886000 ↗MalfunctionSep 22, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857118 ↗MalfunctionSep 14, 2026Explosion
It was reported that the ice pack that came inside item CURFAK300RV1H- FAK,COMPLETE,CURAD,175PC/KIT exploded within the first aid kit and got everything wet inside.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763068 ↗
Other First Aid Kit with drug devices
- NAR 85-4661North American Rescue, LLC · First Aid Kit With Drug1 recall0 reports
- NAR 85-4742North American Rescue, LLC · First Aid Kit With Drug1 recall0 reports
- Welly WLY1043Welly Health Pbc · First Aid Kit With Drug1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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