TRUEplus TRUEplus 5 bevel Pen Needle 31G/6mm - 100ct boxRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00021292010782), received between Jun 7, 2022 and Mar 14, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “No Flow” (8 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

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2025No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATES THAT HER BASAGLAR INSULIN PEN WILL NOT ASPIRATE HER INSULIN. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR 1 MONTH. THE CUSTOMER IS NOT USING COMPATIBLE PRODUCT. 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 21607574 ↗
• MalfunctionNov 4, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER REPORTED COMPLAINT OF INACCURATE DISPENSE, STATING THAT THE 31G PEN NEEDLES DID NOT DISPENSE THE INSULIN. CUSTOMER REPORTED COMPLAINT FOR 2 BOXES OF THE PEN NEEDLES: ADDITIONAL REPORT REFERENCE NUMBER (B)(4). THE PACKAGE HAD NOT BEEN 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. THE 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 20597952 ↗
• MalfunctionOct 17, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CONSUMER REPORTED COMPLAINT FOR INACCURATE DISPENSE/ASPIRATION OF THE 31G PEN NEEDLES STATING THAT HE HAD USED 20 OF THE PEN NEEDLES AND THAT 10 HAD BEEN "CLOGGED." THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THIS IS NOT THE FIRST TIME THE CUSTOMER IS USING THE PRODUCT OUT OF THIS PACKAGE; CUSTOMER COULD NOT CONFIRM EXACTLY HOW LONG HE HAS BEEN USING THE PRODUCT. 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 20470607 ↗
• MalfunctionOct 1, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR INACCURATE DISPENSE OF THE TRUEPLUS PEN NEEDLES. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. DAUGHTER WAS CONCERNED THE PEN NEEDLES WERE NOT DISPENSING THE CORRECT AMOUNT OF INSULIN. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR 3 WEEKS. THE CUSTOMER IS USING COMPATIBLE PRODUCT, AND THE PEN NEEDLE IS ALIGNED PROPERLY. 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 20346702 ↗
• MalfunctionDec 12, 2023Material Twisted/Bent; No Flow; Material Twisted/Bent; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER CALLED AND STATED THAT SHE HAS TWO BOXES OF THE 31G PEN NEEDLES AND WITH BOTH BOXES, SHE NOTICED THAT SOME OF THE NEEDLES ARE BENT AND SOME OF THE NEEDLES ARE NOT ASPIRATING CORRECTLY; ADDITIONAL REPORT REFERENCE NUMBER (B)(4). THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CUSTOMER DOES NOT RECALL HOW LONG SHE HAS BEEN USING THE PRODUCT. CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS ALIGNED PROPERLY. 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 18311262 ↗
• MalfunctionDec 12, 2023Material Twisted/Bent; No Flow; Material Twisted/Bent; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER CALLED AND STATED THAT SHE HAS TWO BOXES OF THE 31G PEN NEEDLES AND WITH BOTH BOXES, SHE NOTICED THAT SOME OF THE NEEDLES ARE BENT AND SOME OF THE NEEDLES ARE NOT ASPIRATING CORRECTLY; ADDITIONAL REPORT REFERENCE NUMBER (B)(4). THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR ABOUT ONE MONTH. CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS ALIGNED PROPERLY. 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 18311055 ↗
• MalfunctionApr 13, 2023Infusion or Flow Problem; Infusion or Flow Problem

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CONSUMER REPORTED COMPLAINT OF INACCURATE DISPENSE FOR THE 31G PEN NEEDLES. CUSTOMER STATED THAT IN ORDER FOR HIM TO GET HIS 5 UNITS OF INSULIN, HE HAS TO PUMP THE INJECTION PEN UP TO 10 AND PUSH HARD UNTIL THE INSULIN IS DISPENSED. CUSTOMER ALSO STATED THAT THIS ISSUE HAS CAUSED HIM TO WASTE INSULIN. CUSTOMER STATED THAT THIS HAS HAPPENED WITH AT LEAST WITH FIVE OF THE PEN NEEDLES. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THIS IS NOT THE FIRST TIME THE CUSTOMER USED THE PRODUCT OUT OF THIS PACKAGE; CUSTOMER STATED HE HAS USED HALF THE BOX. 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 16731285 ↗
• MalfunctionJan 10, 2023No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CONSUMER REPORTED COMPLAINT THE 31G PEN NEEDLES WERE NOT ASPIRATING. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS ALIGNED PROPERLY. 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 16132061 ↗
• MalfunctionNov 8, 2022Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES (31G). WIFE IS CALLING ON BEHALF OF THE CUSTOMER. WIFE STATED THAT WHEN SHE PUTS THE PEN NEEDLE ONTO THE INSULIN PEN, THE NEEDLES BEND. CUSTOMER IS NOT USING A COMPATIBLE PEN WITH THE PEN NEEDLES. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE SINCE (B)(6) 2022. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756086 ↗
• MalfunctionJul 8, 2022No Flow; No Flow

  CONSUMER REPORTED COMPLAINT OF INACCURATE DISPENSE FOR THE 31G TRUEPLUS PEN NEEDLES. CUSTOMER STATED THE PEN NEEDLES WERE NOT DISPENSING THE INSULIN. CUSTOMER REPORTED SAME COMPLAINT FOR DIFFERENT PEN NEEDLE LOT NUMBER: ADDITIONAL REPORT REFERENCE NUMBER 114765-1. CUSTOMER STATED SHE HAS BEEN USING THE TRUEPLUS BRAND OF PEN NEEDLES FOR 3-4 YEARS. THE PACKAGE HAD NOT BEEN 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 14959737 ↗
• MalfunctionJun 7, 2022Defective Component; Detachment of Device or Device Component; Defective Component; Detachment of Device or Device Component

  CONSUMER REPORTED COMPLAINT FOR THE 31G TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT THE NEEDLE FALLS OFF WHEN PUTTING THE CAP BACK ON AFTER ADMINISTERING HIS INSULIN. CUSTOMER WAS CONCERNED AS SEVERAL HAVE FALLEN OFF AND HE STATED THAT IT COULD BE DANGEROUS IF A HUMAN OR ANIMAL STEPPED ON IT. CUSTOMER HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE FOR ONE WEEK. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. CUSTOMER STATED 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 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 14621311 ↗