TRUEplus TRUEplus SINGLE-USE INSULIN syringes 28 gauge needle 1.0cc insulinRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00021292005795), received between May 4, 2022 and Dec 5, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “No Flow” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED THAT THE 28G SYRINGES DID NOT ASPIRATE. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CUSTOMER IS NOT USING THE SYRINGES FOR INSULIN ADMINISTRATION; CUSTOMER STATED HE IS USING THE SYRINGES TO ADMINISTER THE MEDICATION TRIMIX FOR SEXUAL DYSFUNCTION. CUSTOMER STATED HE HAS BEEN USING THE SYRINGES FOR 2 YEARS. 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 20854000 ↗
• MalfunctionMay 4, 2022Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SYRINGES. PHARMACIST IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS USING THE SYRINGES TO ADMINISTER LEUPROLIDE, A FERTILITY DRUG. PHARMACIST STATED THAT THE SYRINGES ARE PRE-FILLED WITH 80 UNITS OF LEUPROLIDE. PHARMACIST STATED THAT THE PHARMACY HAS BEEN DOING THIS FOR OVER 15 YEARS. CUSTOMER STATED THAT THE SYRINGES HAD A SOLID, WHITE SUBSTANCE IN THE SYRINGE. THE CUSTOMER HAD CALLED THE PHARMACY PRIOR TO INJECTING THE DRUG; PHARMACY HAD ADVISED THE CUSTOMER TO ADMINISTER THE MEDICATION. AFTER ADMINISTERING THE MEDICATION, THE WHITE SUBSTANCE WAS STILL THERE IN THE SYRINGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL INTERVENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. THE CUSTOMER IS OUT OF INTENDED USE- PRODUCT IS INTENDED FOR INSULIN USE ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14282130 ↗

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-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
• 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-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-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-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