TRUEplusRecalls & reported problems across all models

We found 37 models of TRUEplus by Trividia Health, Inc. in the FDA's device registry (GUDID). Together they are named in 269 adverse event reports in the FDA's MAUDE database, received between Jun 21, 2018 and Sep 11, 2026 — classified as 16 injuries, 253 malfunctions.

The most frequently reported specific device problem is “No Flow” (98 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported TRUEplus problems

TRUEplus models

37 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TRUEplus TRUEplus Ketone Test Strips

  Nitroprusside, Ketones (Urinary, Non-Quant.)
  33 reports
• TRUEplus TRUEplus SINGLE-USE INSULIN syringes 31 gauge needle 1.0cc insulin

  Syringe, Piston
  25 reports
• TRUEplus TRUEplus 5 bevel Pen Needle 32G/4mm - 100ct box

  Needle, Hypodermic, Single Lumen
  23 reports
• TRUEplus TRUEplus 5 bevel Pen Needle 31G/5mm - 100ct box

  Needle, Hypodermic, Single Lumen
  20 reports
• TRUEplus TRUEplus SINGLE-USE INSULIN syringes 31 gauge needle 0.5cc insulin

  Syringe, Piston
  19 reports
• TRUEplus TRUEplus SINGLE-USE INSULIN syringes 31 gauge needle 0.3cc insulin

  Syringe, Piston
  18 reports
• TRUEplus TRUEplus 5 bevel Pen Needle 31G/8mm - 100ct box

  Needle, Hypodermic, Single Lumen
  18 reports
• TRUEplus TRUEplus SINGLE-USE INSULIN syringes 29 gauge needle 1.0cc insulin

  Syringe, Piston
  14 reports
• TRUEplus TRUEplus 5 bevel Pen Needle 31G/6mm - 100ct box

  Needle, Hypodermic, Single Lumen
  11 reports
• TRUEplus TRUEplus Pen Needles 5Bevel - 32G 4mm

  Needle, Hypodermic, Single Lumen
  10 reports
• TRUEplus TRUEplus 3-Bevel Pen Needle 32G/4mm - 100ct box

  Needle, Hypodermic, Single Lumen
  9 reports
• TRUEplus TRUEplus STERILE pen needles 32 GAUGE x 5/32"

  Needle, Hypodermic, Single Lumen
  7 reports
• TRUEplus TRUEplus 3-Bevel Pen Needle 31G/6mm - 100ct box

  Needle, Hypodermic, Single Lumen
  7 reports
• TRUEplus TRUEplus 3-Bevel Pen Needle 31G/5mm - 100ct box

  Needle, Hypodermic, Single Lumen
  6 reports
• TRUEplus TRUEplus SINGLE-USE INSULIN syringes 30 gauge needle 1.0cc insulin

  Syringe, Piston
  5 reports
• TRUEplus TRUEplus Sterile Lancets

  Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
  4 reports
• TRUEplus TRUEplus SINGLE-USE INSULIN syringes 30 gauge needle 0.5cc insulin

  Syringe, Piston
  4 reports
• TRUEplus TRUEplus 3-Bevel Pen Needle 31G/8mm - 100ct box

  Needle, Hypodermic, Single Lumen
  4 reports
• TRUEplus TRUEplus SINGLE-USE INSULIN syringes 29 gauge needle 0.5cc insulin

  Syringe, Piston
  3 reports
• TRUEplus TRUEplus STERILE pen needles 31 GAUGE x 5/16"

  Needle, Hypodermic, Single Lumen
  3 reports
• TRUEplus TRUEplus Pen Needles - 5Bevel

  Needle, Hypodermic, Single Lumen
  3 reports
• TRUEplus TRUEplus Sterile Lancets

  Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
  2 reports
• TRUEplus TRUEplus SINGLE-USE INSULIN syringes 28 gauge needle 1.0cc insulin

  Syringe, Piston
  2 reports
• TRUEplus TRUEplus SINGLE-USE INSULIN syringes 30 gauge needle 0.3cc insulin

  Syringe, Piston
  2 reports
• TRUEplus TRUEplus STERILE pen needles 31 GAUGE x 3/16"

  Needle, Hypodermic, Single Lumen
  2 reports
• TRUEplus TRUEplus Sterile Pen Needles

  Needle, Hypodermic, Single Lumen
  2 reports
• TRUEplus Good Neighbor Pharmacy TRUEplus Sterile Lancets

  Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
  2 reports
• TRUEplus TRUEplus Pen Needles 5Bevel - 31G 8mm

  Needle, Hypodermic, Single Lumen
  2 reports
• TRUEplus Sunmark TRUEplus Sterile Lancets

  Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
  1 report
• TRUEplus TRUEplus lancets - 33Gauge

  Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
  1 report
• TRUEplus TRUEplus Sterile Lancets

  Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
  1 report
• TRUEplus TRUEplus STERILE pen needles 31 GAUGE x 1/4"

  Needle, Hypodermic, Single Lumen
  1 report
• TRUEplus TRUEplus Pen Needles - 5 Bevel

  Needle, Hypodermic, Single Lumen
  1 report
• TRUEplus Good Neighbor Pharmacy TRUEplus Sterile Lancets

  Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
  1 report
• TRUEplus TRUEplus Pen Needles 31 GAUGE x 3/16"

  Needle, Hypodermic, Single Lumen
  1 report
• TRUEplus TRUEplus Pen Needles 31 GAUGE x 1/4"

  Needle, Hypodermic, Single Lumen
  1 report
• TRUEplus TRUEplus Pen Needles-5Bevel - 31G 5mm

  Needle, Hypodermic, Single Lumen
  1 report

Recent TRUEplus adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Break; No Flow

  Patient problems: Wheal(s)

  MAUDE report 50735663 ↗
• 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 ↗
• MalfunctionApr 27, 2026Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER REPORTED THAT THE NEEDLES ON SOME OF THE SYRINGES WERE BENT. PER CUSTOMER THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER ADVISED THAT ALL SYRINGES WERE IN THEIR PROTECTIVE COVERS. CUSTOMER HAS BEEN USING THE PRODUCT FOR 1 MONTH. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE SYRINGES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25003598 ↗
• MalfunctionMar 17, 2026Failure to Align; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER ADVISED THAT THE PEN NEEDLES ARE NOT ALIGNING WITH HIS HUMALOG KWIK PEN AND THAT WHEN THE PEN NEEDLE DOES WORK, SOMETIMES THE INSULIN IS NOT ASPIRATING. PER CUSTOMER THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER HAS BEEN USING THE PEN NEEDLES SINCE (B)(6) 2026. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621527 ↗
• MalfunctionMar 16, 2026No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATES THAT THE SYRINGE WILL NOT DRAW UP THE MEDICATION. PER CUSTOMER 1 OUT OF 6 WASN'T WORKING. PER CUSTOMER THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER STARTED USING THE SYRINGES 1 MONTH AGO. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605207 ↗
• MalfunctionMar 11, 2026No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. PER CUSTOMER THE PEN NEEDLES DID NOT DISPENSE THE INSULIN. CUSTOMER STATED SHE HAD CONTACTED THE PHARMACY ON THE DAY OF THE CALL FOR ASSISTANCE AND HAD BEEN ADVISED TO CONTACT THE MANUFACTURER. PER CUSTOMER THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED AND HAD BEEN OPENED ON THE DAY OF THE CALL. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. CUSTOMER REPORTED FEELING DIZZY; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: Dizziness

  MAUDE report 24569447 ↗
• 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 ↗
• MalfunctionMar 3, 2026Material Twisted/Bent; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT THE PEN NEEDLES SOMETIMES DID NOT DISPENSE THE INSULIN OR DISPENSED ONLY HALF THE DOSAGE. CUSTOMER ALSO REPORTED THAT THE PEN NEEDLES ARE TOO TIGHT ON HER INJECTION PENS AND AFTER BEING USED THE NEEDLE LOOKS BENT. CUSTOMER IS USING BOTH COMPATIBLE AND NON-COMPATIBLE PRODUCT. PER THE CUSTOMER THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER STATED THAT SHE HAD USED 50 OR MORE OF THE PEN NEEDLES. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495913 ↗
• MalfunctionMar 2, 2026Break

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS LANCETS. CUSTOMER STATED THAT AFTER TESTING, SHE ATTEMPTED TO RE-CAP THE NEEDLE BUT THE NEEDLE BROKE; PER THE CUSTOMER, SHE COULDN'T FIND THE NEEDLES. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER DID NOT MENTION HOW LONG SHE HAS BEEN USING THE LANCETS. AT THE TIME OF THE CALL, THE CUSTOMER FELT 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 24479846 ↗
• MalfunctionFeb 17, 2026No Flow

  CONSUMER REPORTED INACCURATE DISPENSE COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THE INSULIN DOES NOT GET DISPENSED FROM THE PEN NEEDLE. PER THE CUSTOMER THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR LESS THAN A MONTH. THE CUSTOMER IS NOT USING COMPATIBLE PRODUCT. CUSTOMER STATED SHE WOULD CONTACT THE PHARMACY FOR THE CORRECT PEN NEEDLES FOR HER PEN INJECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365067 ↗
• MalfunctionFeb 12, 2026No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES, STATING THAT THE SYRINGE DID NOT ASPIRATE. THE CUSTOMER STATED SHE IS NOT USING THE SYRINGES FOR INSULIN, THE DR. HAD RECOMMENDED USING THEM FOR HER ALLERGY SHOTS; CUSTOMER STATED SHE HAS BEEN USING THEM FOR ABOUT TWO YEARS. PER THE CUSTOMER THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE SYRINGES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24325294 ↗
• MalfunctionFeb 9, 2026No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. CALLER STATED THAT SOMETIMES THE PEN NEEDLES DID NOT DISPENSE THE INSULIN. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT SINCE ON (B)(6) 2025. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24294145 ↗
• MalfunctionFeb 6, 2026No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THE PEN NEEDLES WERE NOT DISPENSING THE INSULIN. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER IS NOT USING COMPATIBLE PRODUCT. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284210 ↗
• MalfunctionFeb 6, 2026No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT 4 OF THE PEN NEEDLES DID NOT DISPENSE THE INSULIN. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283748 ↗
• MalfunctionFeb 5, 2026Product Quality Problem; Difficult to Remove; Failure to Align

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES NOT ALIGNING WITH COMPATIBLE PEN NEEDLE INJECTOR. CUSTOMER STATED THAT THE PEN NEEDLE WAS NOT ALIGNING AND WAS GETTING STUCK WHEN ATTEMPTING TO REMOVE. CUSTOMER ALSO REPORTED THAT THE NEEDLES "FEEL LIKE NAILS." COMPLAINT WAS REPORTED BY E-MAIL AND CONTACT MADE WITH CUSTOMER VIA TELEPHONE. PER THE CUSTOMER THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR 1 MONTH. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268374 ↗

Other Trividia Health, Inc. products

• TRUE METRIX31 models · 4,546 reports · 2 recalls
• TRUE METRIX AIR16 models · 693 reports · 1 recall
• TRUEtrack21 models · 445 reports
• TRUE METRIX PRO5 models · 23 reports · 1 recall
• TRUEbalance3 models · 67 reports
• TRUE METRIX GO3 models · 2 reports · 1 recall
• TRUE FOCUS2 models · 48 reports