TRUEplus TRUEplus 3-Bevel Pen Needle 32G/4mm - 100ct boxRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00021292012816), received between Jul 7, 2020 and Dec 13, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2022No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES; COMPLAINT WAS INITIALLY REPORTED VIA E-MAIL AND CUSTOMER WAS CONTACTED BY TELEPHONE. CUSTOMER STATED THAT 32G PEN NEEDLES DID NOT ALWAYS DISPENSE HIS HUMLIN N INSULIN; CUSTOMER STATED THAT NOTHING COMES OUT WHEN THE PLUNGER IS DEPRESSED. CUSTOMER STATED THAT HE HAS BEEN USING THIS BRAND OF PEN NEEDLES FOR OVER A YEAR. CUSTOMER STATED THAT HE HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE FOR SEVERAL WEEKS. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM THEY WERE 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 15970576 ↗
• MalfunctionSep 26, 2022Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CONSUMER REPORTED COMPLAINT THAT TWO OF THE 32G PEN NEEDLES WERE BENT. CUSTOMER HAS BEEN USING THE PEN NEEDLES FOR SEVERAL MONTHS. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER DID NOT CLAIM THEY WERE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED. NO FURTHER INFORMATION WAS OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15485751 ↗
• MalfunctionNov 30, 2021Compatibility Problem; Compatibility Problem

  CONSUMER REPORTED COMPLAINT FOR PEN NEEDLE NOT ALIGNING WITH COMPILABLE PEN NEEDLE INJECTOR. CUSTOMER STATED THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE SINCE (B)(6) 2021. THE CUSTOMER IS 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 12899826 ↗
• MalfunctionOct 21, 2021Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT 32G PEN NEEDLES WERE BENT OR WARPED. SON IS CALLING ON BEHALF OF THE CUSTOMER. 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 12673467 ↗
• MalfunctionMay 27, 2021Material Integrity Problem; No Flow; Material Integrity Problem; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE PEN NEEDLES. CUSTOMER STATED SHE HAD PURCHASED TWO BOXES, SAME LOT NUMBER, OF THE 32G TRUEPLUS PEN NEEDLES, AND THAT SHE HAD USED PEN NEEDLES FROM ONE OF THE BOXES. CUSTOMER STATED THAT THE PEN NEEDLES DID NOT DISPENSE THE INSULIN, IT WOULD CLOG AND THE FLOW OF INSULIN WOULD STOP. CUSTOMER STATED THAT THIS HAPPENED WITH EVERY OTHER PEN NEEDLE. CUSTOMER STATED THAT THE NEEDLES HURT UPON INSERTION. CUSTOMER ALSO STATED THAT THE PEN NEEDLE HAD COME OFF THE INJECTOR AND HAD GOTTEN STUCK IN HER ABDOMEN. CUSTOMER STATED THE FIRST TIME THIS HAPPENED SHE HAD REMOVED THE PEN NEEDLE HERSELF, AND THE SECOND TIME SHE HAD ASKED A CO-WORKER, WHO IS A SURGEON, TO REMOVE THE PEN NEEDLE FROM HER ABDOMEN (CUSTOMER WAS AT WORK AT THE TIME). AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER IS USING COMPATIBLE PRODUCT. CUSTOMER STATED SHE HAS BEEN USING THE TRUEPLUS PEN NEEDLE BRAND FOR ABOUT 3-4 MONTHS. CUSTOMER STATED SHE DID NOT HAVE ANY PEN NEEDLES LEFT FROM THE FIRST BOX, AND THAT SHE HAS NOT YET USED ANY PEN NEEDLES FROM THE SECOND BOX.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 11897641 ↗
• MalfunctionApr 5, 2021No Flow; No Flow

  CONSUMER REPORTED COMPLAINT OF INACCURATE DISPENSE OF THE PEN NEEDLES STATING THAT SOME DID NOT INJECT HER INSULIN. CUSTOMER HAS BEEN USING THE PRODUCT FOR ABOUT ONE MONTH. CUSTOMER STATED THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER IS USING COMPATIBLE PRODUCT (HUMALOG QWIK PEN) AND THE PEN NEEDLE IS PROPERLY ALIGNED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. THE PEN NEEDLE LOT MANUFACTURER¿S EXPIRATION DATE IS 01/31/2025 AND OPEN VIAL DATE IS APPROXIMATELY ONE MONTH AGO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11613783 ↗
• MalfunctionDec 28, 2020No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE PEN NEEDLES. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER DID NOT NEED ANY MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER HAS BEEN USING THESE PEN NEEDLES FOR SEVERAL WEEKS, USING WITH COMPATIBLE PRODUCTS AND THE PEN NEEDLES WERE PROPERLY ALIGNED. CUSTOMER WAS CONCERNED THE PRODUCT WAS UNABLE TO ADMINISTER WIFE'S INSULIN OR INACCURATE DISPENSE HER INSULIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11085138 ↗
• MalfunctionNov 5, 2020Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR BENT PEN NEEDLES. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURERS EXPIRATION DATE IS 10/31/2024 AND OPEN VIAL DATE IS SEPTEMBER 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10795401 ↗
• MalfunctionJul 7, 2020Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR BENT INNER PART OF PEN NEEDLE. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE PEN NEEDLE LOT MANUFACTURER¿S EXPIRATION DATE IS 06/30/2024 AND OPEN VIAL DATE IS UNDISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10242388 ↗