TechLITE PEN NEEDLES 238131Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00015482238315), received between Dec 31, 2018 and Aug 9, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (7 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2022Insufficient Flow or Under Infusion; Material Twisted/Bent; Insufficient Flow or Under Infusion; Material Twisted/Bent

  CUSTOMER STATES THAT SHE HAS BEEN A PARAMEDIC FOR 30 YEARS AND SHE STATES SHE HAD AN A1C OF BETWEEN 5-6 WHILE USING THE COMFORT EZ PEN NEEDLES UP UNTIL SHE BEGAN USING THE TECHLITE PEN NEEDLES ON (B)(6) 2022. SINCE THEN, HER A1C HAS INCREASED TO 7.1 PER HER PHYSICIAN AND SHE FEELS THAT THIS IS DUE TO NOT BEING ABLE TO PROPERLY DOSE INSULIN DUE TO THE NEEDLES BENDING AND NOT KNOWING HOW MUCH INSULIN WAS BEING ABSORBED. SHE STATES THAT ABOUT 3-4 DAYS AFTER STARTING THE TECHLITE, ONE OF THE NEEDLES BROKE OFF AND STAYED IN HER STOMACH, BUT THAT SHE WAS ABLE TO REMOVE IT WITHOUT MEDICAL INTERVENTION. SHE HAS NOT STARTED ANY NEW MEDICATIONS OR HAD ANY CHANGES IN DOSES. SHE IS TYPE 2 DIABETIC. SHE CAN SEE THE BUBBLE WHEN SHE IS PRIMING, AND SHE HOLDS THE NEEDLE IN PLACE TO THE COUNT OF 7 OR 8. WHEN PULLING THE NEEDLE, SHE FINDS THAT IT IS BENT AT 90° AND/OR REALIZES THAT THERE IS INSULIN IS ON HER CLOTHES. SHE FEELS LIKE END OF NEEDLE IS DULL AND SHE WILL NOT BE USING THEM ANYMORE. LOT: B46ZP1 - 2026-01-12. PART 238131. CALLER STARTED USING THEM (B)(6) 2022 AND PURCHASED THEM AT CVS PHARMACY. SHE GIVES INJECTIONS INTO HER STOMACH AT 90° AND HER BLOOD GLUCOSE CONTINUES TO RISE AND THEN SHE

  Patient problems: Foreign Body In Patient

  MAUDE report 15191073 ↗
• MalfunctionJul 22, 2022Break; Material Fragmentation; Leak/Splash; Dull, Blunt; Material Twisted/Bent; Break; Material Fragmentation; Leak/Splash; Dull, Blunt; Material Twisted/Bent

  CUSTOMER STATES THAT SHE HAS BEEN A PARAMEDIC FOR 30YRS AND SHE STATES SHE HAD AN A1C OF BETWEEN 5-6 WHILE USING THE COMFORT EZ PEN NEEDLES UP UNTIL SHE BEGAN USING THE TECHLITE PEN NEEDLES ON (B)(6) 2022 SINCE THEN HER A1C HAS INCREASED TO 7.1 PER HER PHYSICIAN AND SHE FEELS THAT THIS IS DUE TO NOT BEING ABLE TO PROPERLY DOSE INSULIN DUE TO THE NEEDLES BENDING AND NOT KNOWING HOW MUCH INSULIN WAS BEING ABSORBED. SHE STATES THAT ABOUT 3-4D AFTER STARTING THE TECHLITE ONE OF THE NEEDLES BROKE OFF AND STAYED IN HER STOMACH BUT THAT SHE WAS ABLE TO REMOVE IT WITHOUT MEDICAL INTERVENTION. SHE HAS NOT STARTED ANY NEW MEDICATIONS OR HAD ANY CHANGES IN DOSES. SHE IS TYPE 2 DIABETIC. SHE CAN SEE THE BUBBLE WHEN SHE IS PRIMING AND SHE HOLDS THE NEEDLE IN PLACE TO THE COUNT OF 7 OR 8. WHEN PULLING THE NEEDLE SHE FINDS THAT IT IS BENT AT 90° AND/OR REALIZES THAT THERE IS INSULIN IS ON HER CLOTHES SHE FEELS LIKE END OF NEEDLE IS DULL. SHE GIVES INJECTIONS INTO HER STOMACH AT 90° AND HER BG CONTINUES TO RISE AND THEN SHE FINDS THAT THE INSULIN HAS NOT GONE INTO HER AND THAT THE NEEDLE HAD BENT OR SHE FINDS THAT IT HAS LEAKED OUT AND NOT BEEN ABSORBED AND SHE CANNOT GIVE MORE INSULIN BECAUSE SHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15083754 ↗
• MalfunctionMar 18, 2020Material Twisted/Bent; Material Twisted/Bent

  CUSTOMER FOUND 12 PEN NEEDLES THAT WERE BENT AT A 90 DEGREE ANGLE AFTER REMOVING THE SAFETY CAP. THE NEEDLES WEREN'T USED, THEY WERE BRAND NEW. HE DISPOSED OF THE FAULTY NEEDLES. USER ALSO NOTICED THAT THE BLUE SAFETY CAP WASN'T THERE TO COVER THE NEEDLE AND STATED THE CLEAR CAP WAS THE ONLY COVER ON THE PEN NEEDLES.

  Patient problems: No Information

  MAUDE report 9848575 ↗
• MalfunctionMar 17, 2020Material Twisted/Bent; Material Twisted/Bent

  CUSTOMER CALLED BECAUSE HE HAS HAD ABOUT 12 PEN NEEDLES THAT WERE BENT AFTER REMOVING THE SAFETY CAP. THE NEEDLES WEREN'T USED, THEY WERE BRAND NEW. HE SAID THE NEEDLES WERE BENT AT A 90-DEGREE ANGLE. HE DISPOSED OF THEM IN HIS SHARP'S CONTAINER. HE'S HAD THE PEN NEEDLES FOR ABOUT ONE WEEK. HE BELIEVES THERE IS A MANUFACTURER DEFECT. CUSTOMER IS USING NOVOLOG AND BASAGLAR KWIK PENS. VERIFIED THAT HE IS PLACING THE PEN NEEDLE ON HIS INSULIN PEN, TWISTING IT, THEN REMOVING THE CLEAR TOP BY PULLING IT. HE ALSO NOTICED THAT THE BLUE SAFETY CAP WASN'T THERE TO COVER THE NEEDLE. HE STATED THE CLEAR CAP WAS THE ONLY COVER ON THE PEN NEEDLES. WALKED CUSTOMER THROUGH CHECKING A PEN NEEDLE AND BOTH SAFETY CAPS WERE VISIBLE, AND THE NEEDLE WASN'T BENT. LOT Z56W2 - 2024-10-01. PRODUCT 238131. REPLACED DEVICES AND SENT RL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9841279 ↗
• MalfunctionFeb 12, 2019Material Twisted/Bent; Material Twisted/Bent

  CUSTOMER IS USING THE 8MM - 31 GAUGE NEEDLES AND SOME OF THEM, HE CLAIMS ARE BENT. THEY ARE FINE WHEN HE OPENS THEM BUT WHEN HE TRIES TO INJECT THE INSULIN, THEN HE ISN'T GETTING ANY MEDICATION. HE HAS BEEN USING THESE SINCE JULY WITHOUT ANY INCIDENT, SO THEY ARE IMPLYING THAT THERE'S SOMETHING WRONG WITH THE NEEDLE. THEY'RE TRYING TO SAY THAT WHEN HE IS TRYING TO INSERT THE NEEDLE IN HIS SKIN, THEN THAT'S WHEN THE NEEDLE BENDS AND HE IS NOT ABLE TO INJECT. THEY ARE USING HIS STOMACH AND THERE IS NO SCARRING THAT MAY MAKE IT DIFFICULT TO INSERT OR CAUSE BENDING. THIS HAS HAPPED TO ABOUT 3-4 TIMES AND THEY HAVE ABOUT 90 LEFT IN THE BOX. IT DOES PRIME BEFORE INSERTING NEEDLE INTO SKIN. APPARENTLY THE NEEDLE IS NOT PENETRATING THE SKIN AT ALL AND JUST BENDS. THEY FEEL THAT PERHAPS THE NEEDLE ISN'T SHARP ENOUGH.

  Patient problems: No Information

  MAUDE report 8330234 ↗
• MalfunctionFeb 5, 2019Material Twisted/Bent; Material Twisted/Bent

  CUSTOMER IS USING THE 8MM - 31-GAUGE NEEDLES AND SOME OF THEM HE CLAIMS ARE BENT. THEY ARE FINE WHEN HE OPENS THEM BUT WHEN HE TRIES TO INJECT THE INSULIN THEN HE ISN'T GETTING ANY MEDICATION. HE HAS BEEN USING THESE SINCE JULY WITHOUT ANY INCIDENT, SO THEY ARE IMPLYING THAT THERE'S SOMETHING WRONG WITH THE NEEDLE. THEY'RE TRYING TO SAY THAT WHEN HE IS TRYING TO INSERT THE NEEDLE IN HIS SKIN THEN THAT'S WHEN THE NEEDLE BENDS AND HE IS NOT ABLE TO INJECT. THEY ARE USING HIS STOMACH AND THERE IS NO SCARRING THAT MAY MAKE IT DIFFICULT TO INSERT OR CAUSE BENDING. THIS HAS HAPPED TO ABOUT 3-4 TIMES AND THEY HAVE ABOUT 90 DEVICES LEFT IN THE BOX. IT DOES PRIME BEFORE INSERTING NEEDLE INTO SKIN. APPARENTLY, THE NEEDLE IS NOT PENETRATING THE SKIN AT ALL AND JUST BENDS. THEY FEEL THAT PERHAPS THE NEEDLE ISN'T SHARP ENOUGH. PART 238131.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8307123 ↗
• MalfunctionDec 31, 2018Material Twisted/Bent; Material Twisted/Bent

  CUSTOMER IS USING THE TECHLITE PEN NEEDLES AND HAVE BEEN USING THE BRAND FOR ONE YEAR. HE STATED WHEN HE PUTS THE PEN NEEDLE ON TO HIS LANTUS, IT DOESN'T PIERCE THE DEVICE RIGHT AWAY AND CAUSES THE NEEDLE TO BEND. HE IS USING PART (B)(4). VERIFIED THAT THE CUSTOMER IS NOT RE-USING THE PEN NEEDLE. IT IS BENDING ON THE FIRST USE. HE IS STATING THAT IT'S VERY DIFFICULT TO GET THE NEEDLE ON TO THE LANTUS. THEY MUST APPLY PRESSURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8206134 ↗