TRUEplus TRUEplus STERILE pen needles 31 GAUGE x 3/16"Recalls & reported problems
Trividia Health, Inc. · TRUEplus STERILE pen needles 31 GAUGE x 3/16" · Class 2
All models of TRUEplus (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00021292009045), received between Nov 21, 2019 and Oct 14, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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 18, 2026.
Most reported problems
Device problems
- Material Twisted/Bent2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 14, 2020Material Twisted/Bent; Material Twisted/Bent
CONSUMER REPORTED COMPLAINT FOR BENT PEN NEEDLES. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER HAS BEEN USING THE PEN NEEDLES FROM THIS PACKAGE FOR A FEW WEEKS. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS ALIGNED PROPERLY. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM THEY WERE INJURED USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED. CUSTOMER USES COMPATIBLE LANTUS SOLOSTAR AND HUMALOG KWIKPEN PEN INJECTORS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10678472 ↗MalfunctionNov 21, 2019Material Twisted/Bent; Material Twisted/Bent
CONSUMER REPORTED COMPLAINT FOR NEEDLE BENT/BROKEN/WARPED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PEN NEEDLE STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/01/2023 AND OPEN VIAL DATE IS (B)(6) 2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9357951 ↗
Other Needle, Hypodermic, Single Lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page