Relion Insulin Syringe, 1/2ml 328520Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00681131138369), received between Sep 24, 2018 and May 2, 2025 — classified as 1 injury, 77 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (37 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  CONSUMER REPORTED LIQUID IN THE BARREL OF HER SYRINGES. LOT #: 4225143 CATALOG #: 328520 DATE OF EVENT: UNKNOWN SAMPLES: AVAILABLE - SENDING MAIL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949825 ↗
• MalfunctionNov 12, 2024Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED THAT THE SYRINGE WILL NOT DRAW. CONSUMER DOES NOT RE-USE. LOT#: 4036090, CATALOG#: 328520, DATE OF EVENT: UNKNOWN, SAMPLES: DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663607 ↗
• MalfunctionAug 13, 2024Defective Device; Defective Device

  CONSUMER STATED, "THESE ARE THE WORSE SYRINGES I HAVE EVER USED". STATED, THE NEEDLES ARE PAINFUL WHEN TAKING INJECTIONS. STATED, WHEN SHE SHE DRAWS THE INSULIN, THE INSULIN IS FORCED BACK OUT INTO THE VIAL. SHE DOESN'T UNDERSTAND WHY THE INSULIN WILL NOT STAY IN THE BARREL. STATED, THERE IS NO BRUISING OR BLEEDING FROM THE PAINFUL INJECTIONS. DECLINED REPLACEMENT. LOT: 8100697 CATALOG: 928858 DATE OF EVENT: UNKNOWN SAMPLES: YES CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973815 ↗
• MalfunctionJan 26, 2024Leak/Splash; Separation Failure; Leak/Splash; Separation Failure

  CONSUMER REPORTED FOUND 1 SYRINGE WHEN REMOVED THE NEEDLE SHIELD, THE NEEDLE HUB STAYED IN THE SHIELD. OCCD (B)(6) 2023 DC . CONSUMER REPORTED FOUND 1 SYRINGE NEEDLE SHIELD WOULD NOT REMOVE FROM SYRINGE (B)(6) 2023 DC. LOT # 3065237. CATALOG# 328520. SAMPLE STATUS: AWATING SAMPLE. CONSUMER REPORTED FOUND 1 SYRINGE HARD TO PRESS THE PLUNGER WHEN DRAWING AIR INTO SYRINGE DC . CONSUMER REPORTED FOUND 2 SYRINGES FROM THIS BOX WITH EXCESS LUBE INSIDE SYRINGE WHEN DRAWING UP THE INSULIN DC. LOT # 1343554. CATALOG# 328520. DATE OF EVENT: 11/15/2023. SAMPLE STATUS AWATING SAMPLE. CS0069519/SF00018218.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586935 ↗
• MalfunctionJan 26, 2024Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586843 ↗
• MalfunctionJan 26, 2024Contamination; Device Contamination with Chemical or Other Material; Contamination; Device Contamination with Chemical or Other Material

  CONSUMER REPORTED FOUND 1 SYRINGE WHEN REMOVED THE NEEDLE SHIELD, THE NEEDLE HUB STAYED IN THE SHIELD. OCCD (B)(6) 2023(B)(6). CONSUMER REPORTED FOUND 1 SYRINGE NEEDLE SHIELD WOULD NOT REMOVE FROM SYRINGE (B)(6) 2023- (B)(6). LOT # 3065237. CATALOG# 328520. SAMPLE STATUS AWAITING SAMPLE. CONSUMER REPORTED FOUND 1 SYRINGE HARD TO PRESS THE PLUNGER WHEN DRAWING AIR INTO SYRINGE (B)(6). CONSUMER REPORTED FOUND 2 SYRINGES FROM THIS BOX WITH EXCESS LUBE INSIDE SYRINGE WHEN DRAWING UP THE INSULIN (B)(6). LOT # 1343554. CATALOG# 328520. DATE OF EVENT 11/15/2023. SAMPLE STATUS AWAITING SAMPLE. (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586825 ↗
• MalfunctionNov 6, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE RELION INSULIN SYRINGES WERE MISSING THE SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED SCALE MARKINGS ARE MISSING FROM SOME OF THE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18073521 ↗
• MalfunctionOct 16, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THE BD ULTRA-FINE¿ INSULIN SYRINGE PLUNGER ROD WAS DIFFICULT TO MOVE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED WHEN HE PUSHED ON PLUNGER ROD, THE "STOPPER" WILL NOT MOVE PASS NUMBER 15 ON THE BARREL STATED, HE CANNOT PUSH IT ALL THE WAY DOWN TO ZERO BECAUSE THE PLUNGER ROD IS NOT LONG ENOUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940698 ↗
• MalfunctionSep 5, 2023Break; Break

  IT WAS REPORTED THAT THE SHIELD FOR THE RELION INSULINE SYRINGE WAS CRUSHED. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CONSUMER REPORTED FINDING ONE SYRINGE IN BAG WITH A CRUSHED NEEDLE SHIELD STATED, IT WAS INSIDE A NEW BOX PRIOR TO USE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686777 ↗
• MalfunctionMay 26, 2023Break; Break

  IT WAS REPORTED THAT THE BEFORE USE OF THE RELION® INSULIN SYRINGE THE NEEDLE FELL OUT OF ONE SYRINGE WHEN IT WAS TOUCHED WITH A FINGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED, WHEN HE REMOVED NEEDLE SHIELD PRIOR TO INJECTION, THE NEEDLE WAS BENT. STATED, OUT OF THE THREE THAT HE FOUND BENT, THE NEEDLE FELL OUT OF ONE SYRINGE WHEN HE TOUCHED IT WITH HIS FINGER. 3 SYRINGES AFFECTED. LOT: 2283727. CATALOG: 328520. DATE OF EVENT: 2023-05-05. SAMPLES: YES CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015099 ↗
• MalfunctionMay 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE RELION INSULIN SYRINGES HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 SYRINGE WHEN REMOVED NEEDLE SHIELD FROM SYRINGE NEEDLE HUB ASSEMBLY REMOVED WITH SHIELD AND WAS STUCK INSIDE THE SHIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946313 ↗
• MalfunctionMay 10, 2023Break; Break

  IT WAS REPORTED THAT THE RELION INSULIN SYRINGES THUMB PRESS WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT BROKEN/MISSING FROM THE PLUNGER ROD. ALSO REPORTED THAT THE ORANGE PLUNGER CAP IS STUCK IN THE SEAL OF THE BACK. VERBATIM: CONSUMER REPORTED THAT THE THUMB PRESS IS BROKEN/MISSING FROM THE PLUNGER ROD. ALSO REPORTED THAT THE ORANGE PLUNGER CAP IS STUCK IN THE SEAL OF THE BACK. THE ISSUES INVOLVE ONE SYRINGE. LOT #: 2283727 CATALOG #: (B)(4) DATE OF EVENT: UNKNOWN SAMPLES: AVAILABLE - SENDING MAIL KIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16907174 ↗
• MalfunctionDec 16, 2022Contamination; Contamination

  IT WAS REPORTED WHILE USING RELION INSULIN SYRINGES 1/2ML 31 GAUGE THERE WAS FOREIGN MATTER FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WHEN HE PUSHED DOWN ON THE PLUNGER ROD, "CLEAR CLUMPS OF LIQUID" CAME FROM BARREL OF SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15997995 ↗
• MalfunctionDec 15, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 6MM (15/64") WENT THROUGH THE SHIELD AFTER RECAPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE NEEDLE OF ONE SYRINGE WENT THROUGH THE SHIELD AND STUCK HER FINGER AS SHE WAS TRYING TO RE-SHIELD AFTER INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15985700 ↗
• MalfunctionNov 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT 2 RELION INSULIN SYRINGES 1/2ML 31 GAUGE, 6MM (15/64") EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INTIAIL REPORTER: CONSUMER REPORTED FOUND 1 SYRINGE THE TIP OF SYRINGE BROKE/SNAPPED OFF WHEN REMOVED NEEDLE SHIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859398 ↗
• MalfunctionNov 23, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED WHILE USING RELION INSULIN SYRINGES 1/2ML 31 GAUGE, THE PLUNGER WAS DIFFICULT TO MOVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 SYRINGE PLUNGER HARD TO MOVE AFTER 10 UNIT MARKER LOT # 1144293D CATALOG# 328520 DATE OF EVENT UNKNOWN SAMPLE STATUS AWAITING SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859261 ↗
• MalfunctionNov 23, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING RELION INSULIN SYRINGES 1/2ML 31 GAUGE, THERE WAS FOREIGN MATTER FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 SYRINGE WITH A FOREIGN MATTER INSIDE SYRINGE BARREL - HARD PLASTIC OR ROCK SALT LOOKING PIECE LOT #1088077C CATALOG# 328520 DATE OF EVENT UNKNOWN. SAMPLE STATUS AWAITING SAMPLE. CONSUMER REPORTED WITH 1 SYRINGE A FOREIGN MATTER INSIDE BARREL LOT # 1088077A CATALOG# 328520 DATE OF EVENT UNKNOWN. SAMPLE STATUS AWAITING SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859260 ↗
• MalfunctionSep 15, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT LIQUID COMES OUT OF THE 2 BD SYRINGE 0.5ML 31G 6MM S/C U-100 RELION WHEN PLUNGER IS MOVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING IN ALL PACKETS 3-6 SYRINGES LIQUID COMES OUT OF NEEDLE WHEN PLUNGER IS MOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432731 ↗
• MalfunctionDec 10, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT 5 BD 0.5ML SYRINGES WERE UNABLE TO INJECT INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 5 THAT CLOGGED DURING INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981069 ↗
• MalfunctionOct 19, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT THE 0.5ML 31GX6MM U-100 INSULIN SYRINGE EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, HIS REPLACEMENT BOX FROM A PREVIOUS FILE IS ALSO MISSING EXPIRATION DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661932 ↗
• MalfunctionOct 7, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED 0.5ML 31GX6MM U-100 INSULIN SYRINGE DID NOT HAVE AN EXPIRY ON ITS LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THIS BOX AND PACKETS INSIDE DO NOT HAVE EXPIRY DATES. JUST PURCHASED AT STORE TODAY".

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12594964 ↗
• MalfunctionAug 10, 2021Volume Accuracy Problem; Failure to Deliver; Volume Accuracy Problem; Failure to Deliver

  IT WAS REPORTED THAT 0.5ML 31GX6MM U-100 INSULIN SYRINGE EXPERIENCED A CASE OF SCALE MARKING ISSUES, AND UNDER DOSAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER/PET OWNER REPORTED ASKING HOW TO READ THE SCALE MARKINGS ON SYRINGE. HE CHECKED WITH THE PHARMACY FIRST AND WAS MISINFORMED. PET OWNER WAS TOLD FIRST LINE THAT IS LONGER AND DARKER THAN OTHER SCALE LINES, THAT IS ALSO THE MARKER WHEN PLUNGER IS PRESSED COMPLETELY TO THE TOP, IS THE ONE UNIT LINE AND NOT THE ZERO LINE. RESULTED IN GIVING HIS DOG 2 UNITS INSTEAD OF 3 AS PRESCRIBED. PET OWNER DID NOT SEE INSTRUCTIONS ON THE UNIT LINE MEASUREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298923 ↗
• MalfunctionApr 29, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SYRINGE 0.5ML 31G 6MM S/C U-100 RELION SEPARATED FROM THE HUB BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CONSUMER FOUND ONE SYRINGE WITH THE NEEDLE HUB MISSING. VERBATIM: CONSUMER REPORTED FOUND 1 SYRINGE WITH THE NEEDLE HUB MISSING. THINKING ITS IN THE SHIELD LOT # 8203846, CATALOG# 328520, DATE OF EVENT: (B)(6) 2021. SAMPLE STATUS AWAITING SAMPLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11750306 ↗
• MalfunctionApr 27, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 0.5ML 31G 6MM S/C U-100 RELION NEEDLE HUB SEPARATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328520 BATCH NO: 9346553. IT WAS REPORTED WHEN NEEDLE HUB SEPARATES, NEEDLE SHIELD DIFFICULT TO REMOVE. VERBATIM: RELION CONSUMER REPORTED, WHEN NEEDLE SHIELD WAS REMOVED, NEEDLE HUB SEPARATED PRIOR TO INJECTION. STATED, NEEDLE SHIELD WAS HARD TO REMOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11735246 ↗
• MalfunctionApr 23, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A SYRINGE 0.5ML 31G 6MM S/C U-100 RELION HAD FOREIGN MATTER BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED CLEAR OILY SUBSTANCE" ON HER NEEDLE TIP WHEN SHE PUSHED ON PLUNGER. PET OWNER REPORTED SEEING "CLEAR OILY SUBSTANCE" ON HER NEEDLE TIP WHEN SHE PUSHED ON PLUNGER PRIOR TO INJECTION STATED, DID NOT USE THE SYRINGES SHE FOUND WITH THAT "SUBSTANCE"."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720805 ↗