TechLITE Insulin Syringes 0.3mL 31G x 15/64" (6mm) 260314Recalls & reported problems
Arkray USA, Inc. · TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00015482613143), received between Jun 21, 2021 and Jun 21, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Product Quality Problem” (1 report).
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
Device problems
- Product Quality Problem1
Patient problems
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2021Product Quality Problem; Product Quality Problem
PART 260314. LOT 02909043. EXP DATE: 2024-10-20. CALLER IS CLAIMING THAT SHE HAS FOUR BOXES OF INSULIN SYRINGES AND THAT MANY OF THE SYRINGES ARE UNCAPPED WITHIN THE PACKAGING THAT HOLDS THE SYRINGE AND THAT MANY OF THE PACKAGES THAT HOLD THE SYRINGES ARE OF LOW QUALITY IN HER OPINION AND ARE RIPPED OR DAMAGED. CALLER ALSO CLAIMED THAT SHE WAS SHOWING A CUSTOMER HOW TO USE THE INSULIN SYRINGE AND THAT SHE WAS ACCIDENTALLY STUCK BY THE NEEDLE DURING THE DEMONSTRATION AND THAT THE NEEDLE THAT STUCK HER WAS BENT. UPON VISUAL INSPECTION OF OTHER NEEDLES IN THE PACKAGES SHE DID NOT KNOW IF ANYMORE WERE BENT BUT CLAIMED THEY COULD BE BENDING BECAUSE THE CAPS ARE OFF ON A LOT OF THEM. SINCE THE CALLER WAS STUCK WITH THE NEEDLE, SHE DID SEEK MEDICAL TREATMENT AS THAT IS HER COMPANY'S POLICY FOR SUCH AN INCIDENT, AND SHE DID HAVE A BLOOD TEST PERFORMED TO RULE OUT ANY POSSIBLE INFECTIONS THROUGH BLOOD BORNE PATHOGENS, BUT THE NEEDLE SHE WAS STUCK WITH WAS A BRAND NEW NEEDLE OUT OF THE BOX AND SHE WAS THE ONLY PERSON WHO HAD USED IT, SO THE NEEDLE WAS STERILE WHEN IT POKED HER. CALLER STATED THAT SHE DID NOT SELL ANY OF THESE PRODUCTS TO THE CUSTOMER THAT SHE WAS DEMONSTRATING IT TO, BECAUSE
Patient problems: Needle Stick/Puncture
MAUDE report 12035517 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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