Skip to content

TRUEplus TRUEplus SINGLE-USE INSULIN syringes 31 gauge needle 0.5cc insulinRecalls & reported problems

Trividia Health, Inc. · TRUEplus SINGLE-USE INSULIN syringes 31 gauge needle 0.5cc insulin · Class 2

All models of TRUEplus (37)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
19
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00021292005870), received between Oct 7, 2019 and Jan 30, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 2 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Twisted/Bent4
  • Product Quality Problem4
  • Manufacturing, Packaging or Shipping Problem3
  • No Flow3
  • Component Missing2
  • Device Contamination with Body Fluid1
  • Dull, Blunt1
  • Labelling, Instructions for Use or Training Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions14
  • Insufficient Information2
  • Bruise/Contusion1
  • Needle Stick/Puncture1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 30, 2026Dull, Blunt

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. CALLER STATED THAT SOME OF THE NEEDLES IN THE CURRENT LOT OF SYRINGES ARE DULL AND HARD TO GET INTO THE SKIN. PER THE CALLER, THE PRODUCT WAS SEALED AN INTACT WHEN RECEIVED FROM THE PHARMACY. THE CUSTOMER HAS BEEN USING THE PRODUCT SINCE (B)(6) 2025. 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 24221091 ↗
  • MalfunctionDec 18, 2025Product Quality Problem; Product Quality Problem

    CONSUMER REPORTED COMPLAINT FOR PLUNGER OUT OF PROTECTIVE COVER FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. THE CUSTOMER STATED THAT IN THE LAST SEVERAL BOXES OF THE SYRINGES SOME OF THE PLUNGER CAPS WERE OFF. THE CUSTOMER STATED IT DOES NOT AFFECT THE NEEDLE OF THE SYRINGES. PER THE CUSTOMER THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR 2 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: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23837290 ↗
  • MalfunctionDec 1, 2025Material Twisted/Bent; Material Twisted/Bent

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. THE CUSTOMER CALLED CONCERNED THE SYRINGE NEEDLES BENT UPON INSERTION INTO THE SKIN. THE CUSTOMER IS USING A COMPOUNDABLE INJECTION; CUSTOMER WAS ADVISED OUR THE TRUEPLUS SYRINGES ARE MAINLY FOR INSULIN USE. PER THE CUSTOMER THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR 1 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 ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23686847 ↗
  • MalfunctionAug 13, 2025Component Missing; Component Missing

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED THAT ONE OF THE 31G SYRINGES DID NOT HAVE THE PROTECTIVE CAP ON THE SYRINGE AND THE NEEDLE WAS EXPOSED. CUSTOMER STATED THAT THE CAP WAS NOT IN THE BOX OF SYRINGES. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS CUSTOMER STATED SHE WAS NOT STUCK WITH THE NEEDLE AND NO ADVERSE EVENT WAS REPORTED WITH THE USE OF THE PRODUCT. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT SINCE (B)(6) 2025.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22793224 ↗
  • MalfunctionJun 18, 2025No Flow; No Flow

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. THE CUSTOMER STATED THAT THE 31G SYRINGES WERE NOT "LETTING OUT THE AIR" WHICH IN TURN DOES NOT DISPENSE THE CORRECT AMOUNT OF INSULIN. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE SINCE 05/25/2025. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE SYRINGES. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22286172 ↗
  • MalfunctionJan 24, 2025Product Quality Problem; Product Quality Problem

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES, STATING THAT THE PLUNGER ON THE 31G SYRINGES DID NOT WORK. COMPLAINT WAS INITIALLY REPORTED VIA E-MAIL AND CUSTOMER WAS CONTACTED BY TELEPHONE. CUSTOMER STATED HE IS USING THE SYRINGES TO ADMINISTER INSULIN TO HIS DOG. CUSTOMER STATED THAT ON 3 OUT OF THE LAST 14 SYRINGES "THE PLUNGER SEAL IS STUCK IN THE END OF THE BARREL AND THE PLUNGER PULLS OFF OF IT WHEN PULLING BACK." THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. NO SYMPTOMS OR MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21229954 ↗
  • MalfunctionNov 27, 2024Component Missing; Component Missing

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED THAT OUT OF THE BOX OF 100 31G SYRINGES, 1 WAS MISSING THE NEEDLE. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. 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 20795299 ↗
  • MalfunctionAug 23, 2024Device Contamination with Body Fluid; Manufacturing, Packaging or Shipping Problem; Device Contamination with Body Fluid; Manufacturing, Packaging or Shipping Problem

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED HE HAD PURCHASED A SEALED BOX OF THE SYRINGES AND HAD FOUND A USED SYRINGE INSIDE THE BOX. CUSTOMER STATED THE SYRINGE HAD BEEN LOOSE AT THE BOTTOM OF THE BOX. CUSTOMER ALSO STATED THERE HAD BEEN NO NEEDLE ON THE SYRINGE. CUSTOMER STATED HE THOUGHT IT MIGHT HAVE BLOOD INSIDE. 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 20050582 ↗
  • MalfunctionJun 14, 2024Product Quality Problem; Product Quality Problem

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES, STATING THAT THE PLUNGER ON THE 31G SYRINGES WAS OUT OF THE PROTECTIVE COVER; CUSTOMER STATED THAT THE ORANGE CAP ON SOME OF THE SYRINGES WAS OFF. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CUSTOMER STATED THAT SHE OPENED THIS BOX A WEEK AND A HALF AGO. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM 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 19539125 ↗
  • MalfunctionApr 23, 2024Product Quality Problem; Product Quality Problem

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES, STATING THAT THE PLUNGER ON THE 31G SYRINGES WAS OUT OF THE PROTECTIVE COVER; CUSTOMER STATED THAT THE ORANGE CAP ON SOME OF THE SYRINGES WAS OFF. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CUSTOMER HAS BEEN USING THE PRODUCT FOR ABOUT 1 MONTH. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM 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 19168537 ↗
  • MalfunctionFeb 2, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED THAT THE ORANGE SAFETY CAP WAS "OFF" FROM TWO OF THE 31G SYRINGES; CUSTOMER STATED SHE NOTICED IT HAD BEEN REMOVED PRIOR TO OPENING THE PACKAGE. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED THE CUSTOMER. CUSTOMER HAS BEEN USING THE PRODUCT FOR 4 DAYS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER DID NOT CLAIM 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 18632533 ↗
  • MalfunctionSep 11, 2023Packaging Problem; Packaging Problem

    CONSUMER REPORTED COMPLAINT FOR SYRINGE IS OUT OF THE PROTECTIVE COVER. CUSTOMER STATES THAT THE TOP PART WHERE SHE REMOVES THE PLUNGER IS MISSING FROM THE SYRINGES, A FEW OF THEM IN THE BAG THE TOP PART OF THE SYRINGES IS NOT ON THE SYRINGES. CUSTOMER STATES THAT ORANGE TOP IS IN THE BAG BUT IT IS ON THE TOP OF SYRINGES. THE SYRINGE IS OUT OF THE PROTECTIVE COVER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE SYRINGE LOT MANUFACTURER¿S EXPIRATION DATE IS 11/27/2027AND OPEN VIAL DATE IS UNDISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17721923 ↗
  • MalfunctionJan 6, 2023Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

    CONSUMER REPORTED COMPLAINT FOR LABELING ISSUE WITH THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. PHARMACIST IS CALLING ON BEHALF OF THE CUSTOMER. PHARMACIST STATED THAT CUSTOMER RETURNED A BOX OF SYRINGES DUE TO THE INCORRECT SYRINGES BEING IN THE BOX: PHARMACIST STATED THAT THE BOX READS 1/2" CC 31-GAUGE SYRINGES, HOWEVER WHAT WAS IN THE BOX WAS THE 1/2 CC 29-GAUGE SYRINGES. PHARMACY STATED THAT BOX WAS SEALED AND INTACT WHEN THEY RECEIVED IT AND WHEN IT WAS 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 16113661 ↗
  • MalfunctionMar 1, 2022No Flow; No Flow

    CONSUMER REPORTED COMPLAINT FOR INACCURATE DISPENSE/ NO ASPIRATION OF THE 31G TRUEPLUS INSULIN SYRINGES. SISTER REPORTED COMPLAINT VIA E-MAIL ON BEHALF OF THE CUSTOMER AND WAS CONTACTED VIA TELEPHONE. CUSTOMER HAS BEEN USING THE SYRINGES FOR ONE WEEK. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER IS CONCERNED THE SYRINGES ARE UNABLE TO ADMINISTER THEIR INSULIN, STATING THAT WHEN THE INSULIN WAS ASPIRATED IT WOULD COME RIGHT BACK OUT OF THE SYRINGE. CUSTOMER HAD OPENED ANOTHER BOX AND HAD TO USE 5 SYRINGES BEFORE ONE WORKED AS INTENDED; IT WAS NOT DISCLOSED IF THE SECOND BOX HAD BEEN THE SAME LOT NUMBER OF 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 13633877 ↗
  • MalfunctionMay 13, 2021No Flow; No Flow

    CONSUMER REPORTED COMPLAINT FOR THE 31G SYRINGES. PHARMACIST IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER HAD RETURNED TWO SYRINGES TO THE PHARMACY STATING THAT THEY DID NOT DISPENSE THE INSULIN. PHARMACIST HAD ALSO ATTEMPTED TO DISPENSE THE INSULIN INTO A NAPKIN AND STATED THAT NOTHING HAD COME OUT. THE CUSTOMER IS USING COMPATIBLE PRODUCT. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED USING THE SYRINGES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 11819274 ↗
  • MalfunctionMar 26, 2021Material Twisted/Bent; Material Twisted/Bent

    CONSUMER REPORTED COMPLAINT FOR SYRINGES STATING THAT THE NEEDLE ON THE 31G SYRINGES BEND WHEN ASPIRATING INSULIN. CUSTOMER HAS BEEN USING THE PRODUCT FOR ABOUT TWO MONTHS. CUSTOMER STATED THE BOX HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. THE SYRINGE LOT MANUFACTURER¿S EXPIRATION DATE IS 06/30/2022 AND OPEN VIAL DATE IS TWO MONTHS AGO.

    Patient problems: Insufficient Information

    MAUDE report 11574107 ↗
  • MalfunctionJan 14, 2021Material Twisted/Bent; Material Twisted/Bent

    CONSUMER REPORTED COMPLAINT FOR SYRINGES STATING THAT THE NEEDLE BENT ON 4 SYRINGES AND SOME OF THE SYRINGES IT WAS DIFFICULT TO REMOVE THE CAP AND BELIEVED THEY HAD GLUE OR CLEAR PLASTIC WHERE THE CAP OF SYRINGE MEETS THE SYRINGE BARREL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE SYRINGES. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE SYRINGE LOT MANUFACTURER¿S EXPIRATION DATE IS 01/29/2023.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 11169915 ↗
  • InjuryJul 3, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    PER CUSTOMER E-MAIL: HELLO, I PURCHASED A SEALED UNOPENED BOX OF YOUR INSULIN SYRINGES FROM A THIRD PARTY DISTRIBUTOR RECENTLY. SEE ALL ATTACHED PHOTOS- I WAS STABBED REACHING INTO A SEALED PACKAGE BY A SYRINGE WITH THE ORANGE COVER OFF INSIDE THE CLOSED BAG. FIRST OFF THAT IS NOT A STERILE SYRINGE, SECONDLY THIS IS THE THIRD SYRINGE OUT OF THE BOX OF 100 THAT WAS UNCAPPED IN A SEALED PACKAGE. I EXPECT SOMETHING DONE ABOUT THIS IMMEDIATELY, OTHERWISE I M CALLING THE FDA ON YOUR COMPANY. I AM FURIOUS AS A DIABETIC FOR 50 YEARS THIS HAS NEVER HAPPENED BEFORE. (B)(6). CUSTOMER CARE E-MAIL TO CUSTOMER: THANK YOU FOR CONTACTING OUR CUSTOMER CARE DEPARTMENT. WE WOULD LIKE TO APOLOGIZE FOR ANY INCONVENIENCE YOU MAY BE EXPERIENCING WHILE USING OUR TRUE BRAND OF PRODUCTS. YOUR HEALTH AND SAFETY ARE OUR NUMBER ONE PRIORITY SO PLEASE ALLOW ONE OF OUR TRAINED STAFF OF CERTIFIED TECHNICIANS TO ASSIST YOU. IN ORDER FOR US TO PROPERLY ASSIST YOU WITH YOUR BLOOD GLUCOSE MONITORING DEVICE, PLEASE PROVIDE YOUR PHONE NUMBER AND A REPRESENTATIVE WILL CONTACT YOU TO FURTHER ASSIST YOU. CUSTOMER RESPONDED VIA E-MAIL: I LOOK FORWARD TO THAT BUT IT CAN BE DIFFICULT GETTING HOLD OF ME. ASK THEM TO LEAVE A

    Patient problems: Needle Stick/Puncture

    MAUDE report 10228224 ↗
  • MalfunctionOct 7, 2019Material Twisted/Bent; Material Twisted/Bent

    CONSUMER REPORTED COMPLAINT FOR WARPED SYRINGE NEEDLE. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOM OF BRUISING. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF WARPED SYRINGE NEEDLE OR SYMPTOM.. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL A TEST OF THE PRODUCT WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/15/2021 AND OPEN VIAL DATE IS UNDISCLOSED.

    Patient problems: Bruise/Contusion

    MAUDE report 9162768 ↗

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-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-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-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

Other Syringe, Piston devices

All Syringe, Piston devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page