TechLITE PEN NEEDLES 238931Recalls & reported problems
Arkray USA, Inc. · Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. · Class 2
All models of TechLITE PEN NEEDLES (7)
Data updated Oct 16, 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 00015482238919), received between Aug 27, 2018 and Aug 27, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Dull, Blunt” (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 16, 2026.
Most reported problems
Device problems
- Dull, Blunt1
- Material Twisted/Bent1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2018Dull, Blunt; Material Twisted/Bent; Dull, Blunt; Material Twisted/Bent
CALLER SAID NEEDLES ARE BENDING. SHE IS USING HUMALOG KWIKPEN. THE INJECTION PART IS BENDING. SHE CLAIMS NEEDLE BENDS 30-20 DEGREES. 8 MM X 31G (238931). SHE WAS USING A 8 MM PRIOR. SHE HAS BEEN USING OUR NEEDLES FOR ABOUT ONE MONTH. THE NEEDLE HAS BENT ABOUT FOUR TIMES. REPLACED PRODUCT AND SENT RL. POSSIBLE MALFUNCTION THAT MAY CAUSE IMPROPER DOSE OR DELAY IN TREATMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7817737 ↗
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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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