TRUEplus TRUEplus SINGLE-USE INSULIN syringes 31 gauge needle 0.3cc insulinRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00021292005863), received between Feb 12, 2020 and Apr 27, 2026 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (3 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER REPORTED THAT THE NEEDLES ON SOME OF THE SYRINGES WERE BENT. PER CUSTOMER THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER ADVISED THAT ALL SYRINGES WERE IN THEIR PROTECTIVE COVERS. CUSTOMER HAS BEEN USING THE PRODUCT FOR 1 MONTH. 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 25003598 ↗
• MalfunctionAug 6, 2024Product Quality Problem; Dull, Blunt; Product Quality Problem; Dull, Blunt

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES; COMPLAINT WAS INITIALLY REPORTED VIA E-MAIL AND CUSTOMER WAS CONTACTED BY PHONE. CUSTOMER REPORTED COMPLAINT FOR 3 BOXES OF SYRINGES: ADDITIONAL INTERNAL REPORT REFERENCE NUMBERS (B)(4) . CUSTOMER STATED THAT THE UNIT MEASURES PRINTED ON THE SYRINGES ARE "BLURRY" AND APPEAR TO BE DOUBLE PRINTED. CUSTOMER EXPRESSED CONCERN THAT IF THE UNIT MARKING ARE NOT ACCURATE OR HARD TO READ THE INSULIN COULD BE DRAWN INCORRECTLY. CUSTOMER ALSO REPORTED THEY THE SYRINGE NEEDLES ARE NOT SHARP AND SHE IS HAVING A DIFFICULT TIME ADMINISTERING HER MEDICATION. CUSTOMER DID NOT HAVE ANY OF THE SYRINGES STATING SHE HAD DISPOSED OF THEM. 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 19917606 ↗
• MalfunctionAug 5, 2024Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED THAT THE NEEDLES ON THE 31G SYRINGE WERE BENT. THE CUSTOMER STATED THAT WHEN SHE RECEIVED THE SYRINGES FROM THE PHARMACY, THEY HAD NOT BEEN A BOX, THEY HAD BEEN IN A ZIPLOC BAG. CUSTOMER HAS BEEN USING THE PRODUCT FOR ONE MONTH. CUSTOMER STATED DUE TO THE NEEDLES BEING BENT THE SYRINGES DO NOT ADMINISTER THE CORRECT AMOUNT OF INSULIN. CUSTOMER STATED SHE WASTED ABOUT 14 SYRINGES FROM HER LAST BATCH. 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 19907915 ↗
• InjuryJun 10, 2024Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED THAT HE CAN SEE METAL PARTS TEARING AWAY FROM THE TIP OF THE SYRINGES AND THAT IT HURTS HIS ABDOMEN WHEN HE ADMINISTERS HIS INSULIN. CUSTOMER STATED THAT THERE WAS A METAL PIECE STICKING TO THE SYRINGE, AND THAT HE USED HIS FINGER TO REMOVE IT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 19498170 ↗
• MalfunctionJan 25, 2024Contamination /Decontamination Problem; Material Twisted/Bent; Contamination /Decontamination Problem; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED THAT IN A NEW BOX OF THE 31G SYRINGES THEY HAD FOUND A USED SYRINGE WITH A BENT NEEDLE. COORDINATOR HAD INITIALLY SPOKEN WITH CUSTOMER; NO SYMPTOMS OR MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED TO COORDINATOR. CUSTOMER'S INFORMATION HAD BEEN TRANSFERRED TO TECHNICIAN. TECHNICIAN WAS UNABLE TO CONTACT THE CUSTOMER VIA TELEPHONE, NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18584369 ↗
• InjuryDec 7, 2023Component Missing; Component Missing

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CUSTOMER STATED THAT SHE PUT HER HAND TO PULL OUT THE SYRINGES AND SHE GOT STUCK BECAUSE THERE WERE NO CAPS ON SOME OF THE SYRINGES. CUSTOMER DID VERIFY THAT NOT ALL OF THEM ARE MISSING THE COVERS. CUSTOMER DID NOT HAVE TO SEEK ANY MEDICAL ASSISTANCE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18287283 ↗
• MalfunctionOct 18, 2023No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER ADVISED THAT WHEN SHE GOES TO ADMINISTER HER INSULIN, THE 31G SYRINGE DOES NOT ADMINISTER THE ENTIRE DOSE OF THE INSULIN THAT HAD BEEN DRAWN INTO IT. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE 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 THEY WERE INJURED 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 17956423 ↗
• MalfunctionJul 7, 2023No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED THAT THE 31G SYRINGES DID NOT ASPIRATE THE INSULIN ( LEVEMIR). CUSTOMER STATED THIS JUST STARTED WITHIN THE LAST COUPLE OF WEEKS. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER DID NOT CLAIM THEY WERE INJURED USING THE SYRINGES. 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 17280386 ↗
• MalfunctionDec 29, 2021Dull, Blunt; Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion; Dull, Blunt; Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. COMPLAINT WAS INITIALLY REPORTED VIA E-MAIL AND CUSTOMER WAS CONTACTED VIA TELEPHONE. DOCTOR IS CALLING ON BEHALF OF FACILITY. DOCTOR IS USING THE SYRINGES OUTSIDE OF THE PRODUCT'S INTENDED USE OF INSULIN ADMINISTRATION; DOCTOR STATED THAT HE IS USING THE INSULIN SYRINGES TO INJECT BOTOX INTO HIS PATIENTS. DOCTOR STATED THAT THE NEEDLES ON THE SYRINGES WERE DULL OR HAD A "BARB" AT THE END; DOCTOR STATED PATIENTS WERE INFORMING THE STAFF THAT THE SYRINGES WERE CAUSING PAIN. DOCTOR STATED HE HAD ATTEMPTED TO RETURN SYRINGES TO THE PHARMACY WHERE PURCHASED AND THEY HAD REFERRED HIM TO THE MANUFACTURER. DOCTOR STATED HE HAS (B)(4) BOXES, (B)(4) EACH, OF THE 31G SYRINGES, LOT NUMBER NP21023. DOCTOR DECLINED RETURNING TO PHARMACY FOR REPLACEMENT.

  Patient problems: Pain

  MAUDE report 13109651 ↗
• MalfunctionDec 28, 2021Component Missing; Component Missing

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SYRINGES. PHARMACIST HAD REPORTED COMPLAINT TO DISTRIBUTOR ON BEHALF OF THE CUSTOMER. MANUFACTURER WAS ABLE TO ESTABLISH CONTACT WITH PHARMACIST VIA TELEPHONE. PER PHARMACIST, THE CUSTOMER HAD STATED THAT THE PLUNGER INSIDE OF THE SYRINGE IS MISSING; PHARMACIST DID NOT INDICATE ON HOW MANY SYRINGES THIS OCCURRED. THIS WAS NOT THE FIRST TIME THE CUSTOMER HAD USED THE PRODUCT OF THIS PACKAGE; THE SYRINGES HAD BEEN DISPENSED TO THE CUSTOMER ON (B)(6) (50 MONTHS). THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. NO SYMPTOMS AND NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WERE REPORTED. PHARMACIST STATED THAT SHE WILL CONTACT THE CUSTOMER TO REQUEST THEY RETURN THE SYRINGES, AND A RETURN ENVELOPE WAS SENT TO PHARMACIST. PHARMACIST ALSO ADVISED THAT PICTURES OF THE PRODUCT AND THE BOX THAT SYRINGES WERE IN WERE AVAILABLE; PHARMACIST WAS PROVIDED E-MAIL ADDRESS TO FORWARD PICTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13096293 ↗
• MalfunctionNov 10, 2021Dull, Blunt; Material Integrity Problem; Dull, Blunt; Material Integrity Problem

  CONSUMER REPORTED COMPLAINT FOR THE 31G SYRINGES. CUSTOMER STATED SHE STARTED USING THE SYRINGES A FEW DAYS PRIOR AND THAT THIS IS THE FIRST TIME SHE IS USING THIS BRAND. CUSTOMER STATED THAT THE END OF THE NEEDLE HAS "BURS" AND IS NOT AS SMOOTH AS IT SHOULD BE. CUSTOMER STATED IT IS VERY HARD TO INSERT THE NEEDLE INTO HER SKIN AND THAT IT HURTS. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL INTERVENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. CUSTOMER STATED SHE HAD DISCARDED THE SYRINGES SHE HAD USED.

  Patient problems: Pain

  MAUDE report 12787916 ↗
• MalfunctionDec 17, 2020Filling Problem; Filling Problem

  MANUFACTURER RECEIVED COMPLAINT VIA E-MAIL. CONSUMER REPORTED COMPLAINT FOR THE SYRINGES (NO ASPIRATION). CUSTOMER HAD PURCHASED A BOX OF SINGLE-USE SYRINGES ABOUT A MONTH AGO. SINCE THEN A FEW OF THE SYRINGES MALFUNCTIONED WHILE ATTEMPTING TO FILL THEM WITH INSULIN. THE CUSTOMER DID NOT REPORT SYMPTOMS OR MEDICAL ATTENTION. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/12/2023.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11028523 ↗
• MalfunctionSep 10, 2020Break; Material Integrity Problem; Break; Material Integrity Problem

  CONSUMER REPORTED COMPLAINT FOR NEEDLE BREAK, SYRINGE WAS BLACK, AND PLUNGER NOT WORKING. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE SYRINGE LOT MANUFACTURER¿S EXPIRATION DATE IS 04/21/2022 AND OPEN VIAL DATE IS UNDISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10518647 ↗
• MalfunctionAug 24, 2020Filling Problem; Filling Problem

  CONSUMER REPORTED COMPLAINT FOR NO ASPIRATION OF SYRINGES. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE SYRINGE LOT MANUFACTURER¿S EXPIRATION DATE IS 01/125/2021 AND OPEN VIAL DATE IS UNDISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10444470 ↗
• MalfunctionMay 26, 2020Filling Problem; Filling Problem

  CONSUMER REPORTED COMPLAINT FOR INACCURATE DISPENSE/ASPIRATION OF THE SYRINGES. CUSTOMER STATED THAT THE RUBBER PART STICKS ON SOME OF THE SYRINGES. CUSTOMER ALSO STATED THAT SOME OF THE SYRINGES DID NOT HAVE A NEEDLE; CUSTOMER HAD DISCARDED THOSE WITHOUT THE NEEDLE. THE PACKAGE WAS NOT OPENED OR DAMAGED WHEN RECEIVED BY CUSTOMER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER IS NOT CLAIMING THEY WERE INJURED USING THE PRODUCT. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10088444 ↗
• MalfunctionMay 12, 2020Defective Component; Defective Component

  CONSUMER REPORTED COMPLAINT FOR PLUNGER OF TRUE PLUS SYRINGES NOT WORKING. CUSTOMER STATES BLACK STOPPER IS SEPARATING WHEN SHE ATTEMPTS TO PULL SYRINGE DOWN. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE SYRINGE LOT MANUFACTURER¿S EXPIRATION DATE IS 05/12/2022 AND OPEN VIAL DATE IS UNDISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10046319 ↗
• MalfunctionApr 28, 2020Defective Component; Defective Component

  CONSUMER REPORTED COMPLAINT THAT THE PLUNGER ON THE SYRINGES DOES NOT WORK. CUSTOMER STATED THAT WHEN SHE TRIED TO PULL THE PLUNGER UP, THE PLUNGER COMES COMPLETELY OUT. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO ADVERSE EVENTS WERE REPORTED WITH THE USE OF THE PRODUCT. THE MANUFACTURER'S EXPIRATION DATE FOR THE SYRINGES IS 04/21/2022 AND PACKAGE WAS OPENED IN (B)(6) 2020. CUSTOMER STATED THAT SHE NO LONGER HAS ANY SYRINGES LEFT FROM THIS BOX AND SO IS UNABLE TO SEND BACK ANY PRODUCTS FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10005109 ↗
• MalfunctionFeb 12, 2020Break; Break

  CONSUMER REPORTED COMPLAINT FOR SYRINGE NEEDLES BREAKING WHILE WITHDRAWING INSULIN. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE SYRINGE NEEDLE LOT MANUFACTURER¿S EXPIRATION DATE IS FEB 25, 2021 AND OPEN VIAL DATE IS UNDISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9703254 ↗

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-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-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-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