UltiCare 09585Recalls & reported problems
Ultimed, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20357515095859), received between Dec 16, 2021 and Dec 16, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fail-Safe Problem” (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.
Most reported problems
Device problems
- Fail-Safe Problem1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2021Fail-Safe Problem; Material Twisted/Bent
USING ULTICARE SHORT PEN 31G X 8 MM. NEEDLE IS VERY FLEXIBLE AND HAVE SEVERAL ISSUES WITH IT INCLUDING THE NEEDLE BENDING AND PENETRATING THE SAFETY CAP WHEN BRING RECAPPED. ALSO HAVE ONE INSTANCE WHERE THE NEEDLE WAS APPARENTLY BEND BEFORE BEING CAPPED RESULTING IN THE NEEDLE BEING COLLAPSED INTO A SPAGHETTI BOWL. FDA SAFETY REPORT ID # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13026099 ↗
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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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