TechLITE PEN NEEDLES 235131Recalls & reported problems
Arkray USA, Inc. · Insulin Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00015482235314), received between Mar 14, 2025 and Mar 14, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2025Material Fragmentation; Material Fragmentation
THE CUSTOMER STATED THAT HE INJECTED HIMSELF, AND HE'S NOT SURE IF IT WAS A 90-DEGREE ANGLE, AND THE NEEDLE BROKE OFF IN HIS SKIN IN THE NAVEL AREA. THE CUSTOMER SAID THIS IS HIS FIRST TIME SEEING THIS HAPPEN AND HE HAS BEEN USING THIS PRODUCT FOR A WHILE. THE CUSTOMER DID SEEK MEDICAL ATTENTION AT URGENT CARE, BUT THEY TOLD THE CUSTOMER TO GO TO THE ER. THE CUSTOMER STATED THAT HE HAS MOBILITY ISSUES, SO HE DIDN'T GO. I ASKED IF THE CUSTOMER INSERTED THE NEEDLE STRAIGHT IN AND OUT OR A AT 90-DEGREE ANGLE. CUSTOMER SAID STRAIGHT, BUT HE WASN'T SURE BECAUSE HE DOESN'T MEASURE IT ALL THE TIME. HE STATED THAT HE DID TRY PICKING THE NEEDLE OUT USING A TWEEZER. I ADVISED THE CUSTOMER TO SEEK MEDICAL ATTENTION IF HE WAS NOT ABLE TO REMOVE THE NEEDLE WITH A TWEEZER. REPLACED THE PEN NEEDLES AND SENT A RETURN LABEL AND ADVISED OF RETURN THE PRODUCT FOR FURTHER INVESTIGATION.
Patient problems: Foreign Body In Patient
MAUDE report 21604459 ↗
Other Needle, Hypodermic, Single Lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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