TechLITE PEN NEEDLES 232129Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00015482232290), received between Aug 12, 2021 and Mar 20, 2025 — classified as 2 injuries.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2025Material Fragmentation; Material Fragmentation

  CUSTOMER IS USING THE TECHLITE PEN NEEDLES. THE CUSTOMER HAS BEEN USING THE PRODUCTS FOR ABOUT A YEAR. THE CUSTOMER WAS TRYING TO DELIVER INSULIN AND HAD A NEEDLE BREAK OFF AND LODGE IN HER SKIN, AND PART OF THE NEEDLE IS STILL INSIDE THE PLASTIC CAP. SHE CAN SEE THE NEEDLE IN HER SKIN BUT DOES NOT WANT TO SEEK MEDICAL ATTENTION TO REMOVE IT BECAUSE IT WILL COST TOO MUCH. IT IS IN HER LOWER ABDOMEN ON THE RIGHT SIDE. SHE DOES USE THIS AREA OFTEN AND ALTERNATES ON BOTH SIDES OF HER STOMACH. SHE KEEPS THE NEEDLE AT A 90-DEGREE ANGLE, AND THIS IS THE FIRST TIME SHE HAS HAD AN ISSUE. THE CUSTOMER WANTED TO KNOW IF THE NEEDLE WOULD JUST DISSOLVE, AND SHE WOULDN'T NEED TO SEEK MEDICAL ATTENTION. IT WAS EXPLAINED TO HER THAT WE CANNOT GIVE MEDICAL ADVICE AND CAN ONLY RECOMMEND THAT IT IS BEST TO SEEK MEDICAL ATTENTION IF NEEDED. SHE REFUSED TO SEEK MEDICAL ATTENTION AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 21651985 ↗
• InjuryAug 12, 2021Material Twisted/Bent; Material Twisted/Bent

  CUSTOMER SENT EMAIL TO REPORT ISSUE AND ARKRAY FOLLOWED UP WITH CUSTOMER VIA PHONE TO GATHER MORE INFORMATION. PART 232129. LOT A46Z8 - 2025-09-01. CUSTOMER REPORTED THEY RECEIVED A BOX OF TECHLITE 12MM X 29G PEN NEEDLES FROM THE WALGREEN'S PHARMACY ON (B)96) 2021 FOR HER VICTOZA INSULIN PEN. SHE CLAIMS SHE HAS PROBABLY WASTED HALF OF WHAT SHE HAS USED SO FAR BECAUSE THEY WILL NOT PIERCE HER SKIN. SHE CLAIMS SHE LOOKS LIKE SHE HAS BEEN BEATEN AND ABUSED ACROSS HER ABDOMEN. IN ONE EVENING, SHE WENT THROUGH SIX NEEDLES TO GET ONE THAT WOULD GO INTO HER SKIN. SHE CLAIMED THAT INJECTING HER INSULIN SHOULD NOT BE THIS PAINFUL. SHE IS NOT INJECTING NEAR HER NAVEL. SHE IS NOT RE-USING NEEDLES. NEEDLES DO NOT APPEAR TO BE BARBED, AND APPEAR TO BE FINE, BUT WHEN SHE IS TRYING TO INJECT THE NEEDLE, IT APPEARS TO BEND. BEVEL APPEARS TO BE FINE. EXPLAINED THE REPLACEMENT AND RETURN PROCESS. REPLACED NEEDLES AND SENDING A RETURN LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12314098 ↗