TRUEplus TRUEplus SINGLE-USE INSULIN syringes 29 gauge needle 0.5cc insulinRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00021292005818), received between Mar 23, 2022 and Dec 16, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

8 other recalls cover devices cleared under the same FDA submission (K993017); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2025Material Discolored; Material Twisted/Bent; Material Discolored; Material Twisted/Bent

  CUSTOMER CALLED ON (B)(6) 2025, WITH CONCERNS REGARDING ONE OF TWO BAGS OF NEEDLES SHE RECEIVED, WHICH SHE STATED CONTAINED MULTIPLE DEFECTIVE NEEDLES. IN LATE (B)(6) 2025, CUSTOMER DISCARDED TWO OF THE NEEDLES FROM THIS BAG BECAUSE SHE BELIEVED THEY WERE BENT AND A THIRD NEEDLE BECAUSE IT ¿LOOKED LIKE IT WAS DROPPED ON THE FLOOR¿ AFTER SHE REMOVED THE ORANGE CAP. ON (B)(6) 2025, CUSTOMER NOTICED AFTER SHE FILLED A NEEDLE WITH HER LUPRON (LEOPROLIDE ACETATE) MEDICATION THAT THE NEEDLE ¿LOOKS LIKE IT¿S BEEN ON THE STREET, PICKED UP, AND BLEACHED,¿ THAT THE TIP OF THE NEEDLE ¿LOOKS LIKE IT¿S BEEN GLUED TOGETHER,¿ AND THAT SHE WONDERED IF THERE WAS BLOOD IN THE NEEDLE. CUSTOMER SUBSEQUENTLY USED A DIFFERENT NEEDLE FROM THE SAME BAG TO ADMINISTER HER LUPRON INJECTION, BUT AFTERWARDS SHE BECAME CONCERNED THAT THE LUPRON VIAL COULD HAVE BEEN CONTAMINATED BY THE NEEDLE THAT APPEARED DISCOLORED AND MISSHAPEN. THE SAME DAY, CUSTOMER CALLED HER DOCTOR, BUT DID NOT PROVIDE ANY INFORMATION ON THIS INTERACTION, AND GAVE HERSELF A BLOOD DRAW TO TEST FOR STDS AS SHE IS A PHLEBOTOMIST. ALTHOUGH THE RESULTS WERE NEGATIVE AND CUSTOMER WAS NOT EXPERIENCING ANY SYMPTOMS, CUSTOMER STATED IT COULD TAKE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821980 ↗
• MalfunctionOct 24, 2022Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. COMPLAINT WAS RECEIVED VIA E-MAIL FROM DISTRIBUTOR ON BEHALF OF THE CUSTOMER. CUSTOMER STATED IN E-MAIL SHE HAD PURCHASED THREE BOXES OF THE 29G SYRINGES (100 COUNT, SAME LOT NUMBER). CUSTOMER STATED WHEN SHE HAD ATTEMPTED TO ADMINISTER HER MEDICATION, IT HAD BEEN DIFFICULT TO REMOVE THE ORANGE NEEDLE CAP FROM THE SYRINGE. CUSTOMER STATED HER HUSBAND HAD ASSISTED IN REMOVING THE CAP, AND IN DOING SO, THE NEEDLE HAD BENT. CUSTOMER STATED SHE HAD ATTEMPTED TWICE WITH TWO MORE SYRINGES, AND WITH BOTH AN AIR POCKET HAD FORMED, WHICH CUSTOMER HAD BEEN UNABLE TO REMOVE. CUSTOMER STATED SHE HAD BEEN ABLE TO ADMINISTER HER INJECTION USING ANOTHER BRAND OF SYRINGE. CUSTOMER WAS ABLE TO BE CONTACTED VIA TELEPHONE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. CUSTOMER CONFIRMED THAT SHE IT HAD BEEN DIFFICULT TO REMOVE THE CAP AND THAT SHE HAD BEEN UNABLE TO REMOVE THE AIR BUBBLES FROM THE SYRINGES. CUSTOMER WAS OFFERED A REFUND BY MANAGEMENT; CUSTOMER STATED SHE WAS GOING TO CHECK THE COST WITH PHARMACY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657810 ↗
• MalfunctionMar 23, 2022Component Missing; Material Twisted/Bent; Component Missing; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED THAT FROM THE BOX OF 29G SYRINGES, ONE NEEDLE HAD BEEN MISSING AND SOME OF THE NEEDLES WERE BENT AND UNUSABLE; CUSTOMER WAS CONCERNED WITH THE PRODUCT BEING UNABLE TO ADMINISTER THEIR INSULIN. CUSTOMER HAS BEEN USING SYRINGES OUT OF THIS PACKAGE SINCE (B)(6) 2022. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER FEELS 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 13860693 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K993017. One submission often covers many models, so check the product and lot details in each record.

• Z-0119-2019 · Sep 4, 2018 · Terminated
  McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.
• Z-3202-2018 · Aug 24, 2018 · Terminated
  Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly b
• Z-0571-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 29 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6997-21
• Z-0572-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 29 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6998-21
• Z-0574-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 30 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7000-21
• Z-0573-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 30 Gauge, 1/2cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6999-21
• Z-0570-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 28 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6996-21
• Z-0569-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 28 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6995-21. The device is intended to b