TRUEplus TRUEplus Sterile Lancets (REF 743530)Recalls & reported problems
Trividia Health, Inc. · TRUEplus Sterile Lancets · Class 2
All models of TRUEplus (37)
Data updated Oct 16, 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 00021292004460), received between Mar 10, 2026 and Apr 30, 2026 — classified as 2 malfunctions.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2026Material Twisted/Bent
CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS LANCETS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. PER CALLER THE NEEDLE IS BENT WHEN SHE TAKES THE PROTECTIVE COVERING OFF. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER IS NOT CLAIMING TO HAVE BEEN INJURED USING THE LANCETS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045456 ↗MalfunctionMar 10, 2026Product Quality Problem
CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS LANCETS. CUSTOMER STATED THAT WHEN SHE TWISTS THE CIRCLE TOP OF THE LANCET AND PULLS IT OUT, THE WHOLE NEEDLE COMES EASILY OUT OF THE PLASTIC BODY PART; PER CUSTOMER THE NEEDLE IS STUCK INSIDE OF THE CIRCLE TWIST TOP. CUSTOMER STATED SHE DOES NOT GET STUCK BY THE NEEDLE AS IT IS NOT EXPOSED SINCE ITS STILL INSIDE OF THE TWIST TOP. CUSTOMER STATED THIS HAS OCCURRED 4 TIMES. PER CUSTOMER SHE STARTED USING THIS BOX OF LANCETS ON (B)(6) 2026. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE LANCETS AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24559157 ↗
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- FreeStyle 70469Abbott Diabetes Care Inc · Single use only blood lancet without an integral sharps injury prevention feature1 recall0 reports
- Accu-Chek Softclix 11893238160Roche Diabetes Care GmbH · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature8 reports
- Accu-Chek Softclix 05509661001Roche Diabetes Care GmbH · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature5 reports
- TRUEplus TRUEplus Sterile LancetsTrividia Health, Inc. · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature4 reports
- Accu-Chek Softclix 03144844001Roche Diabetes Care GmbH · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature2 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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