TRUEplus TRUEplus STERILE pen needles 31 GAUGE x 1/4"Recalls & reported problems
Trividia Health, Inc. · TRUEplus STERILE pen needles 31 GAUGE x 1/4" · Class 2
All models of TRUEplus (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00021292009052), received between Nov 4, 2019 and Nov 4, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Material Twisted/Bent” (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.
Most reported problems
Device problems
- Material Twisted/Bent1
Patient problems
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 4, 2019Material Twisted/Bent; Material Twisted/Bent
CONSUMER REPORTED COMPLAINT FOR PEN NEEDLE BENT/BROKEN/WARPED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. CUSTOMER IS USING AN INCOMPATIBLE INSULIN PEN WITH PEN NEEDLE. THE CUSTOMER DID REPORT SYMPTOMS OF PAIN DUE TO INFECTION. MEDICAL ATTENTION IS REPORTED AS A RESULT OF PEN NEEDLE USE. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/01/2023 AND OPEN VIAL DATE IS UNDISCLOSED.
Patient problems: Pain; Unspecified Infection
MAUDE report 9271653 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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