TechLITE PEN NEEDLES 236132Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00015482236328), received between Aug 9, 2018 and Dec 11, 2023 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2023Material Fragmentation; Improper Flow or Infusion; Material Fragmentation; Improper Flow or Infusion

  PART 236132. LOT A56L6 - 2025-05-01. CUSTOMER IS USING THE TECHLITE PEN NEEDLES AND STATED THEY WERE ACCIDENTALLY STUCK. CUSTOMER HAS BEEN USING THE PRODUCT FOR ABOUT 30 DAYS. A NEEDLE BROKE OFF AND WAS LODGED IN HIS SKIN AND HE REMOVED IT. HE DID NOT SEEK MEDICAL ATTENTION SINCE HE WAS ABLE TO GET THE NEEDLE OUT OF HIS SKIN AND THE NEEDLE WAS STERILE WHEN THIS HAPPENED. CALLER STATED THE NEEDLE DIDN'T BEND, BUT THE NEEDLE JUST "POPPED", AND THE INSULIN WENT EVERYWHERE, SO HE WASN'T ABLE TO GET THE CORRECT AMOUNT OF INSULIN. HE DIDN'T STICK THE NEEDLE IN ANY AREAS OF CALLOUSED OR HARD SKIN OR IN THE SAME PLACE AS A PREVIOUS PUNCTURE. HE DIDN'T HOLD IT IN PLACE FOR ABOUT FIVE SECONDS BECAUSE HE DIDN'T NEED IT THAT LONG. I SUGGESTED HOLDING IT IN PLACE FOR ABOUT FIVE SECONDS TO ENSURE HE GETS THE CORRECT AMOUNT OF INSULIN. REPLACED PRODUCT AND SENT RETURN LABEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 18300804 ↗
• MalfunctionMar 1, 2023Material Fragmentation; Material Fragmentation

  CUSTOMER WAS GIVING INJECTION AND WAS ABLE TO PRIME THE NEEDLE, BUT WHEN SHE WENT TO INJECT THE INSULIN, IT WOULD NOT INJECT, AND WHEN SHE PULLED THE SYRINGE OUT, THE NEEDLE STAYED IN HER SKIN. SHE WAS ABLE TO PULL THE NEEDLE OUT OF HER SKIN. SHE WILL START A NEW BOX OF PEN NEEDLES AND RETURN THIS ONE TO US FOR INVESTIGATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16458991 ↗
• InjuryFeb 10, 2023Material Fragmentation; Infusion or Flow Problem; Material Fragmentation; Infusion or Flow Problem

  PART 236132. LOT C58F6 - 2027-04-01. CUSTOMER WAS GIVING INJECTION AND WAS ABLE TO PRIME THE NEEDLE, BUT WHEN SHE WENT TO INJECT THE INSULIN, IT WOULD NOT INJECT, AND WHEN SHE PULLED THE SYRINGE OUT, THE NEEDLE STAYED IN HER SKIN. SHE WAS ABLE TO PULL THE NEEDLE OUT OF HER SKIN. SHE WILL START A NEW BOX OF PEN NEEDLES AND RETURN THIS ONE TO US FOR INVESTIGATION. REPLACED DEVICES AND SENT RETURN LABEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 16356817 ↗
• MalfunctionJan 3, 2020Material Twisted/Bent; Material Twisted/Bent

  CUSTOMER IS STATING THAT OVER THE COURSE OF TIME SHE FOUND DEFECTIVE NEEDLES IN HER TECHLITE PEN NEEDLE PRODUCT. SHE IS USING LOT NUMBER Y46ZP5, EXPIRATION 2023-12-01. PART 236132. SHE USES HUMALOG KWIK PENS. SHE STATES THAT SHE IS FINDING DULL NEEDLES THAT WILL NOT GO THROUGH HER SKIN AND SOME ARE COMING IN THE PACKAGING THAT ARE BROKEN OR CROOKED. REPLACED DEVICES AND SENT RL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9547411 ↗
• MalfunctionJan 3, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  CUSTOMER IS USING TECHLITE PEN NEEDLES. PART 236132. LOT Z58E4 - 2024-05-01 - 100CT. SHE STATES OF A BOX OF 100 ABOUT 10 OF THE NEEDLES WOULD NOT PROVIDE HER WITH INSULIN. SHE WOULD LIKE THESE REPLACED. I EXPLAINED THAT WE WOULD SEND OUT A RL AND ASKED THAT SHE WOULD SEND THE UNUSED NEEDLES BACK. REPLACED DEVICES AND SENT RL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9547313 ↗
• MalfunctionJan 2, 2020Material Twisted/Bent; Material Twisted/Bent

  CUSTOMER IS STATING THAT OVER THE COURSE OF TIME SHE FOUND DEFECTIVE NEEDLES IN HER TECHLITE PEN NEEDLE PRODUCT. SHE USES HUMALOG KWIK PENS. SHE STATES THAT SHE IS FINDING DULL NEEDLES THAT WILL NOT GO THROUGH HER SKIN AND SOME ARE BROKEN OR CROOKED.

  Patient problems: No Information

  MAUDE report 9537456 ↗
• MalfunctionDec 23, 2019Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER IS CLAIMING THAT HE IS EXPERIENCING INSULIN FLOW ISSUES. OF A BOX OF 100 ABOUT 10 OF THE NEEDLES WOULD NOT DELIVER INSULIN.

  Patient problems: No Information

  MAUDE report 9509129 ↗
• MalfunctionNov 12, 2019Infusion or Flow Problem; Infusion or Flow Problem

  CALLER SETS AT TWO UNITS TO RELEASE THE AIR THEN DIALS UP TO THE DOSAGE TO THE INSULIN AMOUNT THAT HE'S SUPPOSED TO TAKE. HE STATED THAT THE PLUNGER WAS LOCKED AND HE WAS NOT ABLE TO PRESS IT DOWN. HE WOULD REMOVE THE PEN NEEDLE THEN SCREW IT ON THEN THE INSULIN WOULD RELEASE. SAME THING HAPPENED ON TWO DIFFERENT INSULIN PENS, SO HE BELIEVES THE ISSUE IS THE PEN NEEDLES. THE USER CONFIRMED HE REMOVES THE COVER FROM THE NEEDLE FIRST THEN TWISTS IT ON THE INSULIN PEN. THEN HE WOULD REMOVE THE COVER TO REVEAL THE TOP NEEDLE. HE WOULD ADJUST THE DIAL TO TWO UNITS TO RELEASE THE AIR BUBBLE, BUT IT WOULD JAM. HE WAS NOT ABLE TO RELEASE THE AIR BUBBLE OR INSULIN. HE ALSO REPORTED FINDING ONE BENT NEEDLE AFTER REMOVING THE COVER.

  Patient problems: No Information

  MAUDE report 9309377 ↗
• MalfunctionOct 29, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  CALLER USED TO USE BD PEN NEEDLES. HE WAS SWITCHED TO THE TECHLITE PEN NEEDLE, PART 236132. LOT Y46ZP5 - 2023-12-01. CALLER SETS AT TWO UNITS TO RELEASE THE AIR THEN DIAL UP TO THE DOSAGE TO THE INSULIN AMOUNT THAT HE'S SUPPOSED TO TAKE. HE STATED THAT HE'S NOT ABLE TO PRESS THE PLUNGER DOWN, IT WAS LOCKED SOLID. HE WOULD REMOVE THE PEN NEEDLE THEN SCREW IT ON THEN THE INSULIN WOULD RELEASE. HE FIGURED IT COULDN'T BE THE DIAL UP INSULIN PEN BECAUSE IT HAPPENED ON BOTH DIAL UP INSULIN PENS. HE THINKS THE ISSUE IS THE PEN NEEDLES. HE RECEIVED THE PEN NEEDLES ABOUT TWO MONTHS AGO. I VERIFIED THAT HE DOES REMOVES THE COVER ON THE NEEDLE FIRST THEN TWISTS IT ON THE INSULIN PEN. THEN HE WOULD REMOVE THE COVER TO REVEAL THE TOP NEEDLE. HE WOULD ADJUST THE DIAL TO TWO UNITS TO RELEASE THE AIR BUBBLE, BUT IT WOULD JAM. HE WAS NOT ABLE TO RELEASE THE AIR BUBBLE OR INSULIN. I WALKED HIM THROUGH THE STEPS TO UNSCREW A PEN NEEDLE TO TWIST ON TO THE INSULIN PEN THEN REMOVED THE CAP. HE ADJUSTED THE DIAL TO TWO UNITS AND THE RELEASED INSULIN. HE ALSO MENTIONED AT TIME, HE'S REVEALED A NEEDLE AND THERE WAS ONE BENT. I EXPLAINED THAT WE WILL SEND THE PRODUCT THROUGH TESTING AND WILL SEND A REPLACEM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9249993 ↗
• MalfunctionAug 13, 2019Material Twisted/Bent; Material Twisted/Bent

  CALLER SENT EMAIL SAYING NEEDLES WERE BENT. CALLED CUSTOMER TO GATHER MORE INFORMATION. PART 236132. WHEN SHE TAKES THE FIRST COVER OFF AND WHEN SHE REMOVES THE NEEDLE COVER, THE NEEDLE IS BENT ALONG WITH THE NEEDLE COVER SLEEVE. REPLACED PRODUCT AND SENT RL. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8889381 ↗
• MalfunctionFeb 14, 2019Material Twisted/Bent; Material Twisted/Bent

  CUSTOMER HAS TECHLITE PEN NEEDLES, PART 236132. LOT X56P7. CALLER SAYS THAT THE NEEDLES BEND WHEN HE INJECTS HIS INSULIN. I TRIED TO ADVISE ON HOW TO USE PEN NEEDLES SINCE HE JUST GOT SWITCHED TO OUR BRAND. CUSTOMER IS NOT SATISFIED WITH QUALITY OF PRODUCT AND WANTS REFUND. ADVISED REFUND WILL NEED TO COME FROM PHARMACY. I SUGGEST WE REPLACE THE BOX AND SEND HIM OUT A NEW BOX TO TRY OUT. CUSTOMER SEEMS TO WANT TO BE SWITCHED TO OLD BRAND. I ADVISED INSURANCE WILL HAVE TO TAKE CARE OF THAT. REPLACED PEN NEEDLES AND SENT RETURN LABEL. ADVISED ON HOW TO RETURN PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8340476 ↗
• MalfunctionSep 4, 2018Material Twisted/Bent; Material Twisted/Bent

  CALLER STATES THAT SOMETIMES SHE IS NOT ABLE TO USE OR PRIME INSULIN PEN NEEDLE. SHE IS A DIABETIC EDUCATOR AND STATES THAT SHE KNOWS WHAT SHE IS DOING. SHE DOESN'T LIKE THE PRODUCT AND WILL NOT RECOMMEND TO HER PATIENTS. I HAD HER CHECK TWO OF THEM THAT WOULDN'T WORK YESTERDAY, AND THE NEEDLE WAS BENT. SHE HAS BEEN USING THESE PEN NEEDLES FOR ABOUT TWO MONTHS AND THIS HAS BEEN AN ONGOING ISSUE. I DID MENTION TO TRY TO MAKE SURE THAT THE CAP IS PUT ON DIRECTLY AND MAKE SURE NOT ACCIDENTALLY BENDING THE NEEDLE WHEN PUTTING CAP ON PEN. PART 236132. 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 7842258 ↗
• MalfunctionAug 23, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER IS CLAIMING THAT THEY CANNOT UNSCREW THE PEN NEEDLE OF THEIR PEN UNLESS THE CAP IS OFF.

  Patient problems: No Information

  MAUDE report 7808555 ↗
• MalfunctionAug 22, 2018Improper or Incorrect Procedure or Method; Appropriate Device Problem Term/Code Not Available; Improper or Incorrect Procedure or Method; Appropriate Device Problem Term/Code Not Available

  USER IS NOT ABLE TO USE OR PRIME INSULIN PEN NEEDLE. PROBABLY NEEDLES WERE BENT.

  Patient problems: No Information

  MAUDE report 7804431 ↗
• MalfunctionAug 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER IS CLAIMING THAT THE NEEDLES DO NOT RELEASE INSULIN THE WAY THEY SHOULD AND THAT THE DON'T PENETRATE THE SKIN WELL. CUSTOMER STATED THAT SAME OF THESE NEEDLES ARE DIFFICULT TO PENETRATE THE SKIN AND THEN IF THEY CAN PENETRATE THE SKIN, THE PATIENT HEARS A "POP" NOISE, AND WHEN THE PATIENT PUSHES THE BUTTON TO ADMINISTER THE INSULIN, ONLY A LITTLE BIT OF INSULIN COMES OUT AND THE PROPER DOSAGE IS NOT ADMINISTERED. PATIENT THEN TRIES ANOTHER DEVICE UNTIL HE'S ABLE TO GET THE PROPER DOSE OF INSULIN. CALLER STATED THAT THIS LAST PRESCRIPTION THERE ARE A LOT OF NEEDLES IN THIS BOX THAT ARE NOT WORKING CORRECTLY. CUSTOMER IS DOING INJECTIONS IN HIS BELLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7775999 ↗
• MalfunctionAug 9, 2018Insufficient Flow or Under Infusion; Dull, Blunt; Insufficient Flow or Under Infusion; Dull, Blunt

  PART 236132. CUSTOMER STATED THAT SOME OF THESE NEEDLES ARE DIFFICULT TO PENETRATE THE SKIN AND THEN IF THEY CAN PENETRATE THE SKIN, THE PATIENT HEARS A "POP" NOISE, AND WHEN THE PATIENT PUSHES THE BUTTON TO ADMINISTER THE INSULIN, ONLY A LITTLE BIT OF INSULIN COMES OUT AND THE PROPER DOSAGE IS NOT ADMINISTERED. PATIENT THEN TRIES ANOTHER DEVICE UNTIL HE'S ABLE TO GET THE PROPER DOSAGE OF INSULIN. CALLER STATED THAT THIS LAST PRESCRIPTION THERE ARE A LOT OF NEEDLES IN THIS BOX THAT ARE NOT WORKING CORRECTLY. PATIENT HAS BEEN USING PEN NEEDLES FOR A LONG TIME, AND HAS BEEN USING TECHLITE PEN NEEDLES SINCE (B)(6) 2018. CUSTOMER IS DOING INJECTIONS IN HIS BELLY. REPLACED PEN NEEDLES AND SENT RL. LOT X56P7 - 2022-06-01.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7768576 ↗