TechLITE PEN NEEDLES 238132Recalls & 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
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00015482238322), received between Jan 19, 2018 and Feb 21, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Device Operates Differently Than Expected1
- Failure to Prime1
- Insufficient Flow or Under Infusion1
- Obstruction of Flow1
Patient problems
- No Information2
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2019Obstruction of Flow; Obstruction of Flow
PATIENT CALLING THAT PEN NEEDLES WILL NOT DISPENSE INSULIN.
Patient problems: No Information
MAUDE report 8356972 ↗MalfunctionFeb 14, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
CUSTOMER IS USING TECHLITE PEN NEEDLE PART (B)(4). CUSTOMER IS CLAIMING THAT SEVEN OF THE PEN NEEDLES HAD NO FLOW. VERIFIED INSERTION METHOD OF THE PEN NEEDLE. NO VISUAL DAMAGE. CUSTOMER SAID HE WOULD TRY A DIFFERENT PEN NEEDLE FROM THE BOX AND IT WOULD FLOW FINE. HE HAS BEEN USING PRODUCT FOR A LONG TIME AND NEVER HAD ANY ISSUES. REPLACING BOX OF PEN NEEDLES FOR CUSTOMER AND SENT RETURN LABEL FOR CUSTOMER TO MAIL BACK. EXPLAINED RETURN LABEL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8340528 ↗MalfunctionNov 19, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
CUSTOMER STATES PEN NEEDLE IS MISSING THE NEEDLE.
Patient problems: No Information
MAUDE report 8083720 ↗MalfunctionJan 19, 2018Failure to Prime; Device Operates Differently Than Expected; Failure to Prime; Device Operates Differently Than Expected
CALLER SAID SEVERAL PEN NEEDLES HAVE BENT NEEDLES. WHEN LOOKING INSIDE THE NEEDLE, THE BOTTOM NEEDLE IS BENT, AND UNABLE TO PRIME THE NEEDLE. LOT NUMBER W46ZA9 - 32G - 5/16 OF AN INCH. BLUE STRIPE ON PACKAGE.
Patient problems: No Code Available
MAUDE report 7205058 ↗
Other Needle, hypodermic, single lumen devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.