TRUEplus TRUEplus SINGLE-USE INSULIN syringes 29 gauge needle 1.0cc insulinRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00021292005825), received between Oct 15, 2021 and Mar 16, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “No Flow” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATES THAT THE SYRINGE WILL NOT DRAW UP THE MEDICATION. PER CUSTOMER 1 OUT OF 6 WASN'T WORKING. PER CUSTOMER THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER STARTED USING THE SYRINGES 1 MONTH AGO. 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 24605207 ↗
• MalfunctionDec 30, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. COMPLAINT WAS INITIALLY REPORTED VIA E-MAIL AND CUSTOMER WAS CONTACTED BY TELEPHONE. PER THE CUSTOMER THE BOX THE SYRINGES WERE DELIVERED IN HAD BEEN DAMAGED; CUSTOMER STATED THE BOX OF SYRINGES WAS NOT INSIDE THE OTHER PACKAGING AND THE SYRINGES HAD BEEN EXPOSED. CUSTOMER STATED THAT SHE WAS NOT COMFORTABLE USING THE SYRINGES IN THAT CONDITION. 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 23921433 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. DISTRIBUTOR REPORTED COMPLAINT ON BEHALF OF THE CUSTOMER VIA E-MAIL; (B)(4). CUSTOMER HAD REPORTED OPENING 2 PACKS OF THE SAME TRUEPLUS SINGLE-USE INSULIN SYRINGES AND THAT 20 OF THE SYRINGE NEEDLES HAD CAUSED PAIN WHEN USED. CUSTOMER HAD REPORTED DUE TO THE PAIN AND DISCOMFORT THEY "WAIT UNTIL THE ABSOLUTE LAST SECOND I HAVE BEFORE TAKING MY INSULIN." NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: Pain

  MAUDE report 21864389 ↗
• MalfunctionMar 11, 2025No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED THE SYRINGE WOULD NOT ASPIRATE THE MEDICATION; CUSTOMER STATED THAT 1 SYRINGE OUT OF 6 WASN'T WORKING. THE PACKAGE WAS NOT OPEN FOR 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 21575277 ↗
• MalfunctionJul 3, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES, STATING THAT THE SYRINGE WOULD NOT DRAW IN MEDICATION. CUSTOMER IS NOT A DIABETIC BUT USES THE SYRINGES FOR HER INJECTABLE MIGRAINE MEDICATION. CUSTOMER WAS ADVISED THAT THE TRUE PLUS SYRINGES ARE DESIGNED FOR INSULIN USE ONLY. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR ABOUT 1 MONTH. 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 19671127 ↗
• MalfunctionJun 24, 2024Filling Problem; Improper Flow or Infusion; Filling Problem; Improper Flow or Infusion

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED THAT THE SYRINGE IS AUTO FILLING PAST THE AMOUNT OF INSULIN SHE NEEDS AND IS NOT DISPENSING THE CORRECT AMOUNT OF INSULIN. CUSTOMER STATED IT FILLS UP OVER OR UNDER THE AMOUNT OF INSULIN AUTOMATICALLY. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER IS NOT CLAIMING TO BE INJURED WHILE 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 19597170 ↗
• MalfunctionMay 21, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES, STATING THAT THE 29G SYRINGES DID NOT ASPIRATE. CUSTOMER STATED THAT NEEDLE SEEMED LIKE IT DOES NOT HAVE A HOLE TO PULL IN THE MEDICATION. CUSTOMER IS NOT A DIABETIC AND SHE USES THE SYRINGES FOR HER INJECTABLE MIGRAINE MEDICATION. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE PACKAGE WAS OPENED BY THE CUSTOMER ON OR AROUND (B)(6) 2024. 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 SYRINGES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358186 ↗
• MalfunctionMay 1, 2024Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED THAT SOME OF THE NEEDLES ON THE SYRINGES ARE BENT OR WARPED. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THIS THE FIRST TIME THE CUSTOMER USED THE PRODUCT OUT OF THIS PACKAGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE SYRINGES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19224378 ↗
• MalfunctionApr 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  CONSUMER REPORTED COMPLAINT FOR PHYSICAL HARM WHILE USING THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CARDINAL HEALTH REPORTED COMPLAINT VIA E-MAIL ON BEHALF OF THE CUSTOMER (REFERENCE NUMBER CASE (B)(4) AND CUSTOMER WAS CONTACTED VIA TELEPHONE. CUSTOMER HAS 4 BOXES OF THE SAME LOT NUMBER OF SYRINGES; CUSTOMER INITIALLY REPORTED TO CARDINAL THAT SHE HAD OPENED 2 OF THE BOXES. CUSTOMER HAD STATED THAT 20 OF THE SYRINGE NEEDLES HURT TO USE AND ARE SO PAINFUL THAT DUE TO THE PAIN AND DISCOMFORT SHE WAITS UNTIL THE "THE ABSOLUTE LAST SECOND" TO ADMINISTER HER INSULIN. WHEN CONTACTED BY TELEPHONE BY THE MANUFACTURER CUSTOMER STATED SHE HAD ONLY OPENED 1 BOX AND THAT THE OTHER 3 ARE UNOPENED. CUSTOMER STATED THAT THE SYRINGES WORK BUT THAT THEY HURT AND TEAR HER SKIN. CUSTOMER HAS BEEN USING THE PRODUCT FOR 3 WEEKS. 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; Skin Tears

  MAUDE report 19096476 ↗
• MalfunctionJan 2, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED THE 29G SYRINGES DID NOT ASPIRATE THE INSULIN. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER DID NOT CLAIM TO BE 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 18426890 ↗
• MalfunctionFeb 16, 2023Component Missing; Component Missing

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES; COMPLAINT WAS INITIALLY REPORTED VIA E-MAIL AND CUSTOMER HAD BEEN CONTACTED BY TELEPHONE. CUSTOMER REPORTED THAT 6-8 OF THE 29G SYRINGES HAD BEEN MISSING THE PLUNGER CAP AND THAT ONE HAD BEEN MISSING THE NEEDLE TIP COVER. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CUSTOMER HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE FOR ABOUT ONE MONTH. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER IS NOT CLAIMING TO BE INJURED USING THE SYRINGES AND NO MEDICAL INTERVENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386526 ↗
• MalfunctionDec 13, 2022Dull, Blunt; Material Twisted/Bent; Dull, Blunt; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. FIANCÉ IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER STATED THAT THE SYRINGES ARE NOT SHARP AND THEY DO NOT PUNCTURE THE SKIN. CUSTOMER ALSO STATED THAT THE NEEDLE IS NOT STRAIGHT. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED TY THE CUSTOMER. THIS WAS THE FIRST TIME THE CUSTOMER HAS USED THE PRODUCT OUT OF THIS PACKAGE. CUSTOMER HAD ATTEMPTED TO RETURN SYRINGES TO PHARMACY AND WAS TOLD TO CONTACT MANUFACTURER FOR REFUND. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER DID NOT CLAIM TO BE 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 15968530 ↗
• MalfunctionMar 1, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SYRINGES. CUSTOMER STATED THAT THE 29G 1 CC SYRINGES ONLY HAD FIVE MARKS BETWEEN EACH NUMBER, INSTEAD OF 10. CUSTOMER EXPRESSED CONCERN THAT SHE WAS NOT RECEIVING THE CORRECT AMOUNT OF INSULIN. 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 13638681 ↗
• MalfunctionOct 15, 2021Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion; Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion

  CONSUMER REPORTED COMPLAINT FOR SYRINGES. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER HAD PURCHASED 100 COUNT OF THE 29G SYRINGES AND STATED SOME APPEAR TO HAVE AN EXTRA PIECE OF METAL STICKING OUT OF THEM. CUSTOMER STATED THEY HAVE "BARBS" THAT CATCH HIS SKIN WHEN HE USES THEM, AND THAT THEY HURT AND BRUISE HIS SKIN. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE SYRINGES WAS REPORTED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER.

  Patient problems: Bruise/Contusion; Pain

  MAUDE report 12639796 ↗

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-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-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-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-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-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