TechLITE PEN NEEDLES 234132Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00015482234324), received between Nov 20, 2018 and Apr 21, 2023 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (10 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2023No Flow; No Flow

  PART 234132, LOT C58K9, 2027-07-01 - 100CT. THE CALLER STATES THAT THE NEEDLES ARE BLOCKED, AND NO LIQUID IS COMING OUT, AND HE SOMETIMES NEEDS TO USE UP TO THREE NEEDLES TO DO AN INJECTION. CALLER USES NEEDLES RIGHT AWAY WITHOUT PRIMING AND DOESN'T PRIME NEEDLES BECAUSE INSULIN IS EXPENSIVE. THE CALLER DOES NOT HAVE ANY UNUSED NEEDLES LEFT TO RETURN. HE DOES HAVE ONES THAT DID NOT WORK, BUT ARE USED, BUT I ADVISED HIM NOT TO RETURN THOSE. REPLACED DEVICES FOR CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16787930 ↗
• MalfunctionDec 21, 2021No Flow; No Flow

  CALLER HAS BEEN USING DEVICES FOR ABOUT A WEEK AND IS COMPLAINING THAT SHE ISN'T FEELING THE INSULIN REACTING WITH HER PEN NEEDLE THE WAY THAT IT DOES WITH HER OLD ONES. CALLER STATED THE INSULIN IS NOT RELEASING AND SHE CAN'T HAVE HER BLOOD SUGAR THAT HIGH, INDICATING SHE IS NOT RECEIVING THE FULL DOSE. SHE IS NOT RE-USING SAME PEN NEEDLE. NOT INJECTING IN SCARRED TISSUE AND NOT NEAR NAVEL AREA. EXPLAINED THE RETURN PROCESS AND IMPORTANCE OF SENDING BACK UN-USED ONES. REPLACED PRODUCT AND SENT RETURN LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13053475 ↗
• MalfunctionDec 20, 2021Infusion or Flow Problem; Infusion or Flow Problem

  PATIENT FELT AS IF THEY WEREN'T GETTING ENOUGH INSULIN AND STARTED TO USE THE SAME PEN NEEDLES THAT THEY'RE USED TO. CALLER HAS BEEN USING DEVICES FOR ABOUT A WEEK AND IS COMPLAINING THAT SHE ISN'T FEELING THE INSULIN REACTING WITH HER PEN NEEDLE THE WAY THAT IT DOES WITH HER OLD ONES. CALLER STATED THE INSULIN IS NOT RELEASING AND SHE CAN'T HAVE HER BLOOD SUGAR THAT HIGH, INDICATING SHE IS NOT RECEIVING THE FULL DOSE. SHE IS NOT RE-USING SAME PEN NEEDLE. NOT INJECTING IN SCARRED TISSUE AND NOT NEAR NAVEL AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043136 ↗
• InjuryJun 21, 2021Dull, Blunt; Dull, Blunt

  CUSTOMER HAS TWO BOXES OF OUR TECHLITE PEN NEEDLES, 32-GAUGE X 4MM, LIGHT GREEN COLOR, 100 COUNT, AND SHE STATED SHE HAS USED ABOUT 20 FROM THE BOX. PART 234132. LOT A58X2 - 2025-10-01. CALLER STATED THEY ARE DULL, AND THEY WILL NOT BREAK THROUGH THE SKIN. SHE SAYS SHE MUST PUSH THE NEEDLES A LITTLE TO BREAK INTO THE SKIN. I ASKED THE CUSTOMER AT WHAT ANGLE SHE IS INJECTING THE NEEDLES AND SHE STATED 90 DEGREES. I ASKED HER IF SHE IS INJECTING INTO ANY SCAR TISSUE AND SHE STATED NO. SHE SAID SHE HAS DONE THIS FOR ABOUT 20 YEARS NOW AND SHE HAS USED OUR PRODUCT BEFORE AND NEVER HAD THIS ISSUE. CUSTOMER CONTINUED TO USE DEVICES UNTIL ONE WORKED PROPERLY. I EXPLAINED TO THE CUSTOMER I WAS GOING TO BE REPLACING BOTH BOXES AND SENDING THEM A RETURN LABEL. I EXPLAINED ONCE THEY RECEIVE THE NEW BOXES TO USE THAT PREPAID LABEL TO SEND US BOTH BOXES BACK FOR TESTING. REPLACED DEVICES AND SENT RETURN LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033940 ↗
• MalfunctionMay 17, 2021Infusion or Flow Problem; Material Twisted/Bent; Infusion or Flow Problem; Material Twisted/Bent

  COMPLAINT FROM A USER DUE TO NEEDLES BENDING AFTER BEING INSERTED IN THEIR SKIN. THE USER ALSO CLAIMS THEY DO NOT GET THE FULL AMOUNT OF INSULIN AND NEED TO USE A SECOND NEEDLE. IT WAS CONFIRMED THE PATIENT APPLIES THE CAP CORRECTLY BY PLACING IT STRAIGHT ON, INJECTS AT 90 DEGREE ANGLE AND DOES NOT INJECT INTO SCAR TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11831579 ↗
• MalfunctionMay 7, 2021Material Twisted/Bent; Material Twisted/Bent

  CALLER SAID THESE WERE 32G X 4MM NEEDLES IN A 100CT BOX THAT WAS WHITE IN COLOR. CALLER WAS UNABLE TO FIND LOT OR BATCH NUMBER BUT FOUND PRODUCT NUMBER OF 234132. CALLER SAYS THE NEEDLES THEY USE BEND AFTER BEING INSERTED IN THEIR SKIN. CALLER ALSO SAYS THEY DO NOT GET THE FULL AMOUNT OF INSULIN AND NEED TO USE A SECOND NEEDLE. I MADE SURE CALLER APPLIED CAP CORRECTLY BY PLACING STRAIGHT ON. CALLER INJECTS AT 90-DEGREE ANGLE. CALLER SAID THEY DID NOT INJECT INTO SCAR TISSUE. I TOLD CALLER WE CAN REPLACE THE NEEDLES AND EXPLAINED THE RETURN PROCESS AS WE WOULD LIKE IT BACK FOR SOME TESTING. REPLACED DEVICES AND SENT RL. CONTACTED CUSTOMER AFTER INITIAL CALL AND WAS ABLE TO GATHER THE LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11790231 ↗
• MalfunctionOct 29, 2020Infusion or Flow Problem; Infusion or Flow Problem

  USER CLAIMS THAT THE INSULIN DOES NOT COME OUT. SHE SAID THIS HAS HAPPENED SEVERAL TIMES WITH DIFFERENT BOXES OF NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10753562 ↗
• MalfunctionJul 21, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  PART 234132. CALLER HAS HAD FOUR NEEDLES IN HER CURRENT BOX THAT WILL NOT PRIME AND LET THE INSULIN THROUGH. REPLACED DEVICES AND SENT RL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10305287 ↗
• MalfunctionJun 24, 2020Material Twisted/Bent; Material Twisted/Bent

  PART 234132. CUSTOMER'S DAUGHTER CALLED BECAUSE HER MOM'S PEN NEEDLES KEEP BENDING. SHE STATED THAT SHE'S HAD THEM FOR ABOUT TWO MONTHS OR LONGER. CUSTOMER IS NOT INJECTING IN THE SCAR TISSUE. SHE SAID SHE'S TWISTING THE PEN NEEDLE ONTO THE SYRINGE PROPERLY. CUSTOMER STATED SHE SAID SHE PINCHES THE SKIN THEN INJECTS STRAIGHT INTO HER SKIN. VERIFIED SHE CHANGES HER NEEDLES WITH EACH INJECTION. SHE DOESN'T USE THE SAME NEEDLE TWICE. REVIEWED WITH THE CUSTOMER HOW TO PROPERLY USE THE PEN NEEDLE AND CONFIRMED SHE IS DOING EVERYTHING CORRECTLY. EVERY OTHER NEEDLE OUT OF THE BOX BENDS. REPLACED DEVICES AND SENT RETURN LABEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10191162 ↗
• MalfunctionMay 18, 2020Material Twisted/Bent; Material Twisted/Bent

  CUSTOMER JUST STARTED USING OUR PRODUCTS AND HE IS HAVING ISSUES WITH GETTING THE NEEDLE INTO HIS SKIN AND SOMETIMES BENDING. HE HAS THREE BOXES AND HAS ONLY USED ABOUT 8 OF THEM SO FAR AND HAS BEEN AN ISSUE WITH EACH NEEDLE. CALLER DOESN'T USE SAME INJECTION SITE. CALLER HAS NO SCAR TISSUE AND NOT INJECTING INTO NAVEL. NEVER REUSES NEEDLES. PART 234132. REPLACING TWO BOXES AND SENDING LABEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10066501 ↗
• MalfunctionApr 16, 2020Infusion or Flow Problem; Infusion or Flow Problem

  COMPLAINT REGARDING INSULIN FLOW. THE USER CLAIMS THAT MOST OF THE INSULIN IS INJECTED, BUT SOMETIMES THE FLOW OF THE INSULIN IS COMPROMISED, NOT ALL OF IT COMES OUT, AND OCCASIONALLY 10ML IS LEFT AND WILL NOT COME OUT. CALLER STATED THAT 10-12 NEEDLES FROM THE BOX HAD THIS ISSUE.

  Patient problems: No Information

  MAUDE report 9966365 ↗
• MalfunctionApr 3, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  CUSTOMER SAYS HE PLACES THE PEN NEEDLE ON THE PEN, RELEASES SOME OF IT TO LET OUT THE AIR, AND THEN PLACES THE PEN NEEDLE IN HIS SKIN. MOST OF THE INSULIN IS INJECTED, BUT OCCASIONALLY THE FLOW OF THE INSULIN IS COMPROMISED AND NOT ALL OF IT COMES OUT, AND OCCASIONALLY 10ML IS LEFT AND WILL NOT COME OUT. CALLER STATES THAT 10-12 NEEDLES FROM THE BOX HAS HAD THIS ISSUE. REPLACED DEVICES AND SENT RL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9921340 ↗
• MalfunctionFeb 5, 2020Material Twisted/Bent; Material Twisted/Bent

  COMPLAINT RECEIVED ON TECHLITE PEN NEEDLES LOT Z58F2. THE CUSTOMER IS CLAIMING THAT ABOUT 30 NEEDLES WERE BENT OR BENDING (IN USE ON THE PATIENT SIDE OF THE NEEDLE). THERE WAS NO NEEDLE AT ALL ON ONE OF THE PEN NEEDLES.

  Patient problems: No Information

  MAUDE report 9669783 ↗
• MalfunctionJan 28, 2020Material Twisted/Bent; Material Twisted/Bent

  RECEIVED EMAIL FROM CUSTOMER. CONTACTED CUSTOMER FOR FOLLOW-UP AND TO GATHER MORE INFORMATION. THERE WAS NO NEEDLE AT ALL ON ONE OF THE PEN NEEDLES. SHE HAS BEEN INJECTING SINCE (B)(6) 2018 SO IS NOT NEW TO PEN NEEDLES. SHE STATES THAT OVER 30 NEEDLES BENT IN USE ON THE PATIENT SIDE OF THE NEEDLE. SHE IS INSERTING AT THE 90-DEGREE ANGLE AND THEN REMOVING STRAIGHT OUT. PART 234132. LOT Z58F2 - 2024-05-01. REPLACED DEVICES AND SENT RETURN LABEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9638541 ↗
• MalfunctionDec 16, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  CUSTOMER CAN GET THE PEN NEEDLE ON THE DEVICE. WHEN SHE'S PRIMING, ONLY A SMALL AMOUNT OF INSULIN COMES OUT, AND SHE WOULD TRY AGAIN AND ONLY A LITTLE LIQUID WOULD COME OUT, SO SHE WOULD GRAB ANOTHER PEN NEEDLE AND IT WOULD WORK FINE. CUSTOMER IS NEEDING TO USE NUMEROUS DEVICES TO GET THE PROPER AMOUNT OF INSULIN. ASKED IF THE NEEDLE WAS BENT AND SHE CONFIRMED THAT THE NEEDLES ARE NOT BENT. ASKED IF THERE WAS DAMAGE TO THE PACKAGE AND THERE WAS NO DAMAGE TO THE PACKAGING. PART 234132. LOT Z58F3 - 2024-01-05 - 100CT. REPLACED DEVICES AND SENT RETURN LABEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9473193 ↗
• MalfunctionOct 14, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  CUSTOMER REPORTED THAT THE REPLACEMENT DEVICES FROM HIS ORIGINAL COMPLAINT CALL ON (B)(6) 2019 ARE NOT WORKING ANY BETTER THAN THE COMPLAINT DEVICES HE ORIGINALLY REPORTED ON (B)(6) 2019. TODAY HE STATED THAT HE HAS HAD TO USE FIVE OR SIX DIFFERENT PEN NEEDLES TO PROPERLY INJECT HIS INSULIN. HE CLAIMED THAT THE NEEDLES FEEL DULL OR BLUNT WHEN INSERTING INTO THE SKIN AND ARE VERY PAINFUL AND THAT THE FLOW OF INSULIN IS NOT GOOD, AND HE HAD ONE GET "CLOGGED" TODAY WHEN ATTEMPTING TO INJECT THE INSULIN. CUSTOMER STATED HE ONLY USES THE PEN NEEDLES ONCE AND IS NOT ATTEMPTING TO REUSE THEM. HE STATED HE DOES NOT HAVE ISSUES PUTTING THE PEN NEEDLE ON THE PEN. LOT Z58F3, EXPIRATION 2024-05-01. PART 234132. REPLACED PRODUCT AND SENT RETURN LABEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9187316 ↗
• MalfunctionOct 14, 2019Infusion or Flow Problem; Infusion or Flow Problem

  HE HAD TO USE FIVE OR SIX DIFFERENT PEN NEEDLES TO PROPERLY INJECT HIS INSULIN. HE CLAIMED THAT THE NEEDLES FEEL DULL OR BLUNT WHEN INSERTING INTO THE SKIN AND ARE VERY PAINFUL AND THAT THE FLOW OF INSULIN IS NOT GOOD AND HE HAD ONE GET "CLOGGED" WHEN ATTEMPTING TO INJECT THE INSULIN. CUSTOMER STATED HE ONLY USES THE PEN NEEDLES ONCE AND IS NOT ATTEMPTING TO REUSE THEM. HE DOES NOT HAVE ISSUES PUTTING THE PEN NEEDLE ON THE PEN.

  Patient problems: Missing Value Reason

  MAUDE report 9184469 ↗
• MalfunctionOct 14, 2019Infusion or Flow Problem; Infusion or Flow Problem

  CUSTOMER SUBMITTED A PROBLEM BECAUSE NEEDLE BENDING AND GENERAL DISSATISFACTION AND HIS LACK OF TRUST TO THE PRODUCT. PATIENT HAS SUBMITTED PAIN AND LEAKAGE OF INSULIN WHEN USING VICTOZA PEN. HE HAS ASSESSED NEEDLES AS THE WORSE COMPARE P THOSE WHICH HE WAS USED PREVIOUSLY. HE AFRAID THAT NEEDLE WILL BENT AND BREAK INSIDE THE BODY.

  Patient problems: Missing Value Reason

  MAUDE report 9184441 ↗
• MalfunctionOct 1, 2019Material Twisted/Bent; Material Twisted/Bent

  CUSTOMER STATED THAT HE JUST STARTED USING THESE PEN NEEDLES LAST WEEK. HE SAID THERE'S SOMETHING WRONG WITH THE NEEDLES. HE STATED THAT THE NEEDLE BENDS. HE ALSO SAID IT HURTS HIS FINGER AND HE'S SCARED THE NEEDLE WILL GET STUCK BECAUSE IT BENDS. HE SAID THE NEEDLES ARE INCORRECTLY MADE AND THAT HE GOT A BAD BATCH. HE SAID HE TWISTS THE NEEDLE ON TO THE VICTOZA. HE SAID WHEN HE PULLS THE NEEDLE OUT OF HIS TESTING SITE, HE CAN SEE A FEW DROPS OF INSULIN ON THE TIP OF THE NEEDLE. HE SAID HE'S PRESSING DOWN TO RELEASE IT. HE FEELS THEY ARE NOT AS GOOD AS HIS OTHER NEEDLES. HE'S USING THE SIDE OF HIS STOMACH AND HIS OUTER THIGH. SOMETIMES HE PINCHES THE AREA FOR HIS TESTING SITE. HE IS ONLY USING EACH NEEDLE ONCE. HE DOESN'T TRUST THE NEEDLES. I DID EXPLAIN HOW TO PROPERLY USE THE PRODUCT. REPLACED PEN NEEDLES AND SENT RL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9139051 ↗
• MalfunctionJul 25, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  CUSTOMER IS USING TECHLITE PEN NEEDLES. LOT Y58J3 - 32 GUAGE X 4 MM - 100CT. PART 234132. HE IS USING A "BASAGLAR" PEN THAT HE STATES IS MADE BY LILY KWIKPEN. HE STATES THE INJECTION IS NOT "SMOOTH" AND INSULIN LEAKS FROM THE SIDE. HE DOES NOT BELIEVE THAT THE TECHLITE PEN NEEDLES ARE COMPATIBLE WITH THIS PEN, BUT OUR ADVERTISING STATES IT SHOULD BE. INFORMED CUSTOMER WE CAN REPLACE HIS PEN NEEDLES AND CAN TRY THEM WITH HIS KWIK PEN. INFORMED PRODUCT WILL ARRIVE IN 3 TO 5 BUSINESS DAYS. GAVE INSTRUCTIONS TO SEND PRODUCT BACK WITH RETURN LABEL. PLEASE REPLACE PEN NEEDLES AND SEND RL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8827291 ↗
• MalfunctionJun 4, 2019Material Twisted/Bent; Material Twisted/Bent

  CALLER IS CALLING TO COMPLAIN THAT THE NEEDLES ARE BENDING IN THE PROCESS OF DOING THE INJECTION AND HE MUST PUSH THE PLUNGER VERY HARD TO GET HIS FULL DOSE OF INSULIN. HE IS USING THE LILLY HUMALOG PEN. CUSTOMER ONLY USES THE NEEDLES ONCE. SIZE IS 100CT 0.23 X 4MM 32G. HE SAID THAT IT HAS HAPPENED WITH MULTIPLE BOXES OF NEEDLES. PART 234132. LOT Y58ZC9 - 2023-10-01. REPLACED DEVICES AND SENT RL. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8667623 ↗
• MalfunctionApr 30, 2019Obstruction of Flow; Obstruction of Flow

  THE COMPLAINT DUE TO LACK OF INSULIN PATENCY. SOMETIMES THE INSULIN INJECTION IS POSSIBLE ONLY AFTER USAGE OF 3RD NEEDLE. THE PATIENT USES LANTUS AND VICTOZA, SHE USES THE NEEDLES ONLY ONCE AND HAS NOT NOTICED THE NEEDLES BENDING AT THE NEEDLE TOPS.

  Patient problems: No Information

  MAUDE report 8564069 ↗
• MalfunctionApr 30, 2019Obstruction of Flow; Obstruction of Flow

  THE COMPLAINT DUE TO LACK OF INSULIN PATENCY. SOMETIMES THE INSULIN INJECTION IS POSSIBLE ONLY AFTER USAGE OF 3RD NEEDLE. THE PATIENT USES LANTUS AND VICTOZA, SHE USES THE NEEDLES ONLY ONCE AND HAS NOT NOTICED THE NEEDLES BENDING AT THE NEEDLE TOPS.

  Patient problems: No Information

  MAUDE report 8563863 ↗
• MalfunctionApr 30, 2019Obstruction of Flow; Obstruction of Flow

  LACK OF INSULIN FLOW, SO NEEDLES ARE NOT WORKING PROPERLY. PEN NEEDLES USED WITH LANTUS I HUMALOG QUICK PENS.

  Patient problems: No Information

  MAUDE report 8563801 ↗
• MalfunctionApr 16, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  CALLER IS USING PEN NEEDLES WITH VICTOZA. SOMETIMES HE PUTS ONE ON AND THE INSULIN WILL NOT COME OUT. THE NEEDLE IS NOT BENT AT ALL AND HE ONLY USES THEM ONCE. PART 234132. REPLACED PEN NEEDLES AND SENT RL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8518617 ↗