TRUEplus TRUEplus SINGLE-USE INSULIN syringes 30 gauge needle 0.5cc insulinRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00021292005849), received between May 13, 2022 and May 12, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Component Missing” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2025Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED THAT ABOUT 10 OF THE 30G SYRINGES WERE MISSING THE DOSAGE MARKS ON THE SIDE. THE CUSTOMER STATED THAT SINCE HE WAS UNABLE TO USE THEM, HE HAD DISCARDED THOSE SYRINGES. CUSTOMER STATED HE STILL HAS THE BOX BUT IS NOT SURE IF THERE WERE OTHER SYRINGES THAT WERE ALSO MISSING THE DOSE LINES. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER OPENED THE PACKAGE 25 DAYS PRIOR TO THE CALL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER IS NOT CLAIMING THEY WERE INJURED USING THE SYRINGES AND NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001922 ↗
• MalfunctionNov 5, 2024Component Missing; Component Missing

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. DISTRIBUTOR REPORTED COMPLAINT ON BEHALF OF THE CUSTOMER. CUSTOMER HAD REPORTED THAT ALL OF THE SYRINGES IN THE PACKAGE WERE ¿MISSING THE BLACK RUBBER PIECE INSIDE IT¿ (I.E. THE RUBBER STOPPER). THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR 1 WEEK. NO SYMPTOMS AND NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612593 ↗
• MalfunctionMar 15, 2024Defective Component; Defective Component

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES; COMPLAINT WAS INITIALLY REPORTED VIA E-MAIL AND CUSTOMER WAS CONTACTED VIA TELEPHONE. CUSTOMER STATED THAT THE PLUNGER ON THE 30G SYRINGES WERE NOT WORKING CORRECTLY. CUSTOMER STATED THAT HE HAS TO PUSH THE PLUNGER HARDER THAN USUAL IN ORDER TO ADMINISTER THE INSULIN, AND AS A RESULT, THE SYRINGE NEEDLE WAS CAUSING HIM PAIN. THE CUSTOMER HAS USED MORE THAN HALF OF THE SYRINGES. THE SYRINGES ARE EXPIRED: MANUFACTURER¿S EXPIRATION DATE IS 08/09/2023. CUSTOMER STATED HE IS HAVING THE SAME ISSUE WITH ANOTHER LOT OF THE SYRINGES, INTERNAL REPORT REFERENCE (B)(4). THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: Pain

  MAUDE report 18911866 ↗
• MalfunctionMay 13, 2022Dull, Blunt; Dull, Blunt

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. PHARMACIST IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER REPORTED TO THE PHARMACIST THAT THE NEEDLES ON THE 30G SYRINGES WERE BLUNT, AND THAT THEY WERE NOT ABLE TO PIERCE THE SKIN OR THE INSULIN VIAL. CUSTOMER DID NOT BRING ANY OF THE SYRINGES TO THE PHARMACY, ONLY THE BOX THAT THE SYRINGES HAD COME IN. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. PHARMACIST WAS NOT ABLE TO CONFIRM WHEN THE PRODUCT HAD BEEN DISPENSED TO 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 14397416 ↗

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-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-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-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-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