TRUEplus TRUEplus SINGLE-USE INSULIN syringes 30 gauge needle 0.3cc insulinRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00021292005832), received between Mar 15, 2024 and Jul 24, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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.

• MalfunctionJul 24, 2025Packaging Problem; Packaging Problem

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. PHARMACIST IS CALLING ON BEHALF OF THE CUSTOMER. PHARMACIST HAD DISPENSED THE BOX OF SYRINGES TO THE CUSTOMER ON (B)(6) 2025; WHEN CUSTOMER HAD OPENED THE BOX, THE 30G SYRINGES HAD NOT BEEN PACKAGED IN INDIVIDUAL PLASTIC BAGS. CUSTOMER HAD STATED THAT ALL OF THE SYRINGES WERE AT THE BOTTOM OF THE BOX, AND THAT THE INDIVIDUAL PLASTIC BAGS WERE LAYING ON TOP OF THE SYRINGES. PHARMACIST STATED THAT THE PLASTIC CAP ON THE SYRINGES WAS INTACT. PHARMACIST STATED THE BOX HAD BEEN TAPED SHUT WHEN PHARMACY HAD RECEIVED IT FROM MCKESSON, AND THAT IS HOW THEY DISPENSED IT TO THE CUSTOMER. PHARMACIST ADVISED THAT CUSTOMER WAS REFUNDED IN FULL FOR THE PURCHASE. NO SYMPTOMS OR MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586966 ↗
• 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. 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 18912056 ↗

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-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-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-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-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-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