Insulin Syringe 3/10mL 29G x 8MM 328512Recalls & reported problems

Summary

The FDA's MAUDE database contains 282 adverse event reports that list this exact device (DI 00681131311786), received between Nov 3, 2017 and Jun 10, 2025 — classified as 10 injuries, 272 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (154 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 282 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2025Off-Label Use; Off-Label Use

  PET OWNER REPORTED THE "SCALE MARKINGS" ON THE BARREL WERE "SMUDGED" BEFORE USE. STATED, SHE COULD NOT SEE THE NUMBERS AND SHE DID NOT WANT TO TAKE A CHANCE ON DRAWING UP THE INCORRECT DOSAGE. LOT: UNKNOWN, CATALOG: 328512, DATE OF EVENT: UNKNOWN, SAMPLES: YES. SAMPLES WILL COMING IN WITH A RELATED FILE, (B)(4) AND REPLACEMENT BOX IS GOING OUT FROM THAT FILE AS WELL. THE CONSUMER UNDERSTANDS, WE CANNOT REPLACE THE 8MM SYRINGE. CL. VCOYNE 23MAY2025. UPDATE/ADDITIONAL INFORMATION FROM U.S. CUSTOMER CARE. THE CONSUMER CALLED BACK WITH LOT NUMBER: 4023007. ALSO STATED, THE SCALE MARKINGS WERE MISSING FROM SOME OF THE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180325 ↗
• MalfunctionMar 3, 2025Leak/Splash; Leak/Splash

  CONSUMER REPORTED, WHEN SHE REMOVES THE NEEDLE SHIELD, THE NEEDLE COMES OFF WITH IT AND GETS STUCK IN THE SHIELD. LOT: 4114009, CATALOG: 328512, DATE OF EVENT: UNKNOWN, SAMPLES: YES CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504479 ↗
• MalfunctionFeb 6, 2025Defective Device; Defective Device

  CONSUMER REPORTED FOUND 1 SYRINGE MISSING THE THUMB PRESS ON THE END OF PLUNGER ROD. (B)(6). LOT # 4086147. CATALOG# 328512. DATE OF EVENT (B)(6) 2025. SAMPLE STATUS AWAITING SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21324385 ↗
• MalfunctionJul 25, 2024Volume Accuracy Problem; Volume Accuracy Problem

  WM- RELION OTC EMAIL, 7/3/2024, 6:21:14 AM: REFERENCE # (B)(4). CUSTOMER STATED: RELION U100 31G NOTICING THE ZERO LINES ARE VARYING, ARE NOT CONSISTENT? FOUR SO FAR NOTICED FROM THIS PACK. PURCHASED BEFORE: YES MONDAY. SECOND PURCHASE. RELI 8MM 31G .3CC ITEM # 328512 LOT # UNKNOWN AT THIS TIME. SUPPLIER ID#: (B)(4), SUPPLIER REFERENCE#: PLACEHOLDER, PRODUCT CATEGORY: NON-CONSUMABLE, BRAND NAME: RELION, UPC: 8113131178, LOT#: 0, EXPIRATION DATE: 12/31/2028.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19827758 ↗
• MalfunctionJul 18, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  CONSUMER REPORTED FINDING THE NEEDLE TO HAVE A CLEAR LIQUID COMING OUT OF THEM BEFORE USE. LOT # 3346007 CATALOG# 328512 DATE OF EVENT UNKNOWN SAMPLE STATUS AWAITING SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19779004 ↗
• MalfunctionJul 2, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  CONSUMER REPORTED LIQUID COMING FROM THE SYRINGES, SHE STATED THAT THERE WAS DROPS OF LIQUID ON THE NEEDLE TIPS. LOT #: 3156433 CATALOG #: 328512 DATE OF EVENT: UNKNOWN SAMPLES: DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656426 ↗
• MalfunctionMar 5, 2024Off-Label Use; Device Contamination with Chemical or Other Material; Off-Label Use; Device Contamination with Chemical or Other Material

  PET OWNER REPORTED FINDING CLEAR LIQUID IN BARREL OF SYRINGE PRIOR TO INJECTION.. STATED, SHE IS CONCERNED ABOUT USING THE SYRINGE. STATED, THE LIQUID IS "CLEAR AND OILY" LOOKING. LOT: 3156433 CATALOG: 328512 DATE OF EVENT: UNKNOWN SAMPLES: YES CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839820 ↗
• MalfunctionJan 30, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  CONSUMER REPORTED FOUND 1 SEALED BAG WITH NEEDLE SHIELDS OFF SYRINGE. NO INJURY FROM THIS INCIDENT. DC. LOT # 3121381. CATALOG# 328512. DATE OF EVENT 01/04/2024. SAMPLE STATUS AWAITING SAMPLE. (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610246 ↗
• MalfunctionJan 10, 2024Break; Break

  CONSUMER REPORTED REUSING SYRINGE 4 TIMES A DAY FOR 4 DAYS. THIS SAME SYRINGE BROKE OFF IN RIGHT UPPER THIGH IN LAST NIGHTS INJECTION. CAN'T FIND/SEE IT IN HER SITE. NOR ON THE FLOOR. INFORMED CALLER REASONS NOT TO REUSE. SHE HAS NOT SEEN MEDICAL ATTENTION AS OF YET. NOT SURE IF SHE WILL. - DC LOT # 3191935 CATALOG# 328512 DATE OF EVENT DECEMBER 17, 2023 SAMPLE STATUS DISCARD (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18488618 ↗
• MalfunctionNov 17, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THE BD ULTRA-FINE¿ INSULIN SYRINGE WAS UNABLE TO ASPIRATE. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CONSUMER REPORTED THAT THE SYRINGE WILL NOT DRAW. CONSUMER DOES NOT RE-USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18163094 ↗
• MalfunctionNov 15, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THE BD ULTRA-FINE¿ INSULIN SYRINGE HAD FOREIGN MATTER. THE FOLLOWING WAS RECEIVED BY THE IINITIAL REPORTER: CONSUMER REPORTED MOISTURE IN SYRINGES. CONSUMER DOES NOT RE-USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142888 ↗
• MalfunctionOct 2, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE RELION INSULINE SYRINGE STERILITY WAS COMPROMISED. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 NEEDLE HUB ASSEMBLY WITH UNSHIELDED NEEDLE LAYING IN BAG. THE BAG WAS SEALED. HOWEVER, CALLER STUCK HER FINGER WITH THE UNSHIELDED NEEDLE. SHE IS FIND NO MEDICAL ATTENTION RECEIVED. DC.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17857970 ↗
• MalfunctionAug 3, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERELION INSULIN SYRINGE HAVE LIQUID COMING OUT OF THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER FINDING MORE SYRINGES WITH LIQUID COMING OUT OF NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17454958 ↗
• MalfunctionJul 27, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT 4 OF THE RELION INSULIN SYRINGE 3/10ML 29G X 8MM PLUNGER ROD DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER OWNER REPORTED THE PLUNGER ROD IS DIFFICULT TO MOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410602 ↗
• MalfunctionJul 27, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE RELION INSULIN SYRINGE 3/10ML 29G X 8MM EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED VOICEMAIL FROM PHARMACIST CALLING ON PET OWNERS' BEHALF. RETURNED CALL. STATED, PRIOR TO INJECTION, "CLEAR LIQUID" IS FOUND IN THE BARREL OF SYRINGES. STATED, PET OWNER IS NOT COMFORTABLE USING SYRINGES AND TOOK BOX BACK TO PHARMACIST WHO THEN REPLACED THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17409526 ↗
• MalfunctionJun 20, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE RELION INSULIN SYRINGE 3/10ML 29G X 8MM PLUNGER ROD DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, IT'S HARD TO PUSH THE PLUNGER ROD BECAUSE THE STOPPER IS SLANTED INSIDE BARREL. RETURNED CALL AND LEFT MESSAGE FOR CONSUMER TO CALL ME BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17167861 ↗
• MalfunctionJun 20, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE RELION INSULIN SYRINGE 3/10ML 29G X 8MM STOPPER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED A VOICEMAIL FROM CONSUMER STATING, THE "STOPPER IS SLANTED" MAKING IT DIFFICULT TO USE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17167860 ↗
• MalfunctionJun 13, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE RELION INSULIN SYRINGES EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED A DROP OF LIQUID ON THE NEEDLE TIP WHEN SHE DEPRESSED THE PLUNGER ROD, STATED THAT IT WAS A VERY SMALL AMOUNT BUT SHE WAS CONCERNED BECAUSE SHE HAS NEVER NOTICED IT BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122263 ↗
• MalfunctionMar 28, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE RELION INSULIN SYRINGES EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED WHEN SHE PUSHES ON PLUNGER ROD PRIOR TO DRAWING INSULIN, LIQUID COMES OUT OF THE BARREL ONTO THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16633073 ↗
• MalfunctionMar 24, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING RELION INSULIN SYRINGES 3/10ML 31 GAUGE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE HAVE A LIQUID COMING OUT THE NEEDLE. THE LIQUID IS ALMOST OIL FEELING, ITS THICKER CONSISTENCY AND DOES NOT HAVE AN ORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16613922 ↗
• MalfunctionFeb 21, 2023Contamination; Contamination

  IT WAS REPORTED WHILE USING RELION INSULIN SYRINGE 3/10ML 29G X 8MM FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED LIQUID COMING FROM SYRINGE WHEN DEPRESSING PLUNGER ROD, DURING PRIMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16412270 ↗
• MalfunctionDec 29, 2022Contamination; Contamination

  IT WAS REPORTED THAT THE RELION INSULIN SYRINGE 3/10ML 29G X 8MM EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED SYRINGE WITH A LIQUID THAT CAME OUT OF NEEDLE BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075119 ↗
• MalfunctionDec 29, 2022Contamination; Contamination

  IT WAS REPORTED THAT THE RELION INSULIN SYRINGE 3/10ML 29G X 8MM EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED SYRINGE WITH A LIQUID THAT CAME OUT OF NEEDLE BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075108 ↗
• MalfunctionDec 22, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING RELION INSULIN SYRINGE 3/10ML 29G X 8MM THE NEEDLE HUB SEPARATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WHEN SHE REMOVED NEEDLE SHIELD, NEEDLE HUB SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040256 ↗
• MalfunctionNov 29, 2022Material Separation; Material Separation

  IT WAS REPORTED WHILE USING RELION INSULIN SYRINGE 3/10ML 29G X 8MM THE HUB SEPARATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER THAT SYRINGE SHIELD IS HARD TO DETACH, ONCE DETACHED, NEEDLE HUB SEPARATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15875550 ↗