TechLITE PEN NEEDLESRecalls & reported problems across all models

We found 7 models of TechLITE PEN NEEDLES by Arkray USA, Inc. in the FDA's device registry (GUDID). Together they are named in 62 adverse event reports in the FDA's MAUDE database, received between Jan 19, 2018 and Mar 20, 2025 — classified as 7 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (22 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported TechLITE PEN NEEDLES problems

TechLITE PEN NEEDLES models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TechLITE PEN NEEDLES 234132

  Needle, hypodermic, single lumen
  31 reports
• TechLITE PEN NEEDLES 236132

  Needle, hypodermic, single lumen
  16 reports
• TechLITE PEN NEEDLES 238131

  Needle, hypodermic, single lumen
  7 reports
• TechLITE PEN NEEDLES 238132

  Needle, hypodermic, single lumen
  4 reports
• TechLITE PEN NEEDLES 232129

  Needle, hypodermic, single lumen
  2 reports
• TechLITE PEN NEEDLES 235131

  Needle, Hypodermic, Single Lumen
  1 report
• TechLITE PEN NEEDLES 238931

  Needle, hypodermic, single lumen
  1 report

Recent TechLITE PEN NEEDLES adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryMar 14, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER STATED THAT HE INJECTED HIMSELF, AND HE'S NOT SURE IF IT WAS A 90-DEGREE ANGLE, AND THE NEEDLE BROKE OFF IN HIS SKIN IN THE NAVEL AREA. THE CUSTOMER SAID THIS IS HIS FIRST TIME SEEING THIS HAPPEN AND HE HAS BEEN USING THIS PRODUCT FOR A WHILE. THE CUSTOMER DID SEEK MEDICAL ATTENTION AT URGENT CARE, BUT THEY TOLD THE CUSTOMER TO GO TO THE ER. THE CUSTOMER STATED THAT HE HAS MOBILITY ISSUES, SO HE DIDN'T GO. I ASKED IF THE CUSTOMER INSERTED THE NEEDLE STRAIGHT IN AND OUT OR A AT 90-DEGREE ANGLE. CUSTOMER SAID STRAIGHT, BUT HE WASN'T SURE BECAUSE HE DOESN'T MEASURE IT ALL THE TIME. HE STATED THAT HE DID TRY PICKING THE NEEDLE OUT USING A TWEEZER. I ADVISED THE CUSTOMER TO SEEK MEDICAL ATTENTION IF HE WAS NOT ABLE TO REMOVE THE NEEDLE WITH A TWEEZER. REPLACED THE PEN NEEDLES AND SENT A RETURN LABEL AND ADVISED OF RETURN THE PRODUCT FOR FURTHER INVESTIGATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21604459 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗