Relion Insulin Syringe, 3/10ml x 6mm 328521Recalls & reported problems
Wal-Mart Stores, Inc. · ReliOn Insulin Syringes 3/10mL 31 Gauge, 6mm (15/64") U-100 100count · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Relion insulin syringe is a store-brand syringe for insulin. Its 184 reports include no deaths and 1 injury. Many describe liquid leaking from cracked barrels, scale markings that are missing or crooked, and bent or broken needles. Reports in the last 12 months (1) are down from 12 in the prior 12 months, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 189
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 189 adverse event reports that list this exact device (DI 00681131138383), received between Aug 30, 2018 and Sep 25, 2026 — classified as 1 injury, 188 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (87 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash87
- Device Contamination with Chemical or Other Material23
- Failure to Deliver22
- Off-Label Use16
- Break10
- Volume Accuracy Problem9
- Contamination8
- Defective Device8
Patient problems
- No Clinical Signs, Symptoms or Conditions82
- No Known Impact Or Consequence To Patient69
- No Consequences Or Impact To Patient30
- No Patient Involvement9
- Foreign Body In Patient2
- Blood Loss1
- Hyperglycemia1
- Pain1
Recent adverse event reports
The 25 most recent of 189 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902401 ↗MalfunctionSep 24, 2026Off-Label Use
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883807 ↗MalfunctionSep 24, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883220 ↗MalfunctionSep 24, 2026Off-Label Use
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881721 ↗MalfunctionSep 8, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671395 ↗InjuryNov 13, 2025Break; Break
PET OWNER REPORTED THAT THE SYRINGE NEEDLE BROKE OFF INSIDE OF THE CAT DURING INJECTION. THE CAT WAS TAKEN TO THE VET, HAD X-RAYS DONE AND WAS GIVEN ANTIBIOTICS. THE CONSUMER STATED THAT THE NEEDLE WAS SEEN ON THE X-RAY BUT NOT REMOVED. SHE WAS TOLD THAT IF A LUMP OR INFECTION DEVELOPS, THEY WILL TRY TO SURGICALLY REMOVE THE NEEDLE. I ADVISED CONSUMER TO CONTACT US WITH ANY UPDATES. LOT #: 5097065. CATALOG #: 328521. DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.
Patient problems: Foreign Body In Patient
MAUDE report 23541899 ↗MalfunctionJun 10, 2025Off-Label Use; Off-Label Use
PET OWNER REPORTED "TWO CRACKS" IN THE BARREL OF HER SYRINGE. STATED, WHEN SHE WAS DRAWING HER INSULIN, THE MEDICATION STARTED LEAKING OUT OF THE CRACKS. LOT: UNKNOWN. CATALOG 328521. DATE OF EVENT: 2025-18-05. SAMPLES: YES. STATED, SHE WILL CALL BACK WITH THE LOT NUMBER. THERE IS A RELATED FILE, (B)(4) AND THE SAMPLES ARE COMING BACK WITH THIS FILE. CL. VCOYNE 20MAY2025. UPDATE/ADDITIONAL INFORMATION FROM U.S. CUSTOMER CARE - SEE ATTACHMENTS. THE CONSUMER CALLED BACK WITH LOT NUMBER: 4254133.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22176948 ↗MalfunctionJun 9, 2025Off-Label Use; Volume Accuracy Problem; Off-Label Use; Volume Accuracy Problem
PET OWNER REPORTED SEVERAL ISSUES WITH SYRINGES. STATED, "SCALE MARKINGS/LINES ARE CROOKED" STATED, SOME "SCALE MARKINGS ARE MISSING" STATED, NEEDLE IS BENT BEFORE INJECTION LOT: 4282062, 4191020, 4233018 CATALOG: 328521 DATES OF EVENT: UNKNOWN SAMPLES: NO CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22170380 ↗MalfunctionJun 6, 2025Material Puncture/Hole; Material Puncture/Hole
CONSUMER REPORTED FOUND 2 SYRINGES FROM THIS BOX WITH NEEDLE THRU THE NEEDLE SHIELDS. 1 SYRINGE OF THE 2 SYRINGES LIKE THIS STUCK HER FINGER TODAY. NO MEDICAL ATTENTION WAS NEEDED. SYRINGE WAS UNUSED. DC. LOT # 4282059 CATALOG# 328521 DATE OF EVENT 05.12.2025 AWAITING SAMPLE DATE OF EVENT 05.07.2025 DISCARD SAMPLE STATUS AWAITING SAMPLE CALLER HAS PHOTOS OF TODAY'S SYRINGE WILL SEND TO THIS CASE # THE PHOTOS. (B)(6), (B)(6) 2025. ADDITIONAL INFORMATION. SEE ATTACHED BOTH SYRINGES HAVE THE NEEDLE THRU SHIELD THE ONE THAT STUCK HER, THRU THE SHIELD, (B)(6) 2025. CONSUMER REPORTED FOUND 2 SYRINGES FROM THIS BOX WITH NEEDLE THRU THE NEEDLE SHIELDS. 1 SYRINGE OF THE 2 SYRINGES LIKE THIS STUCK HER FINGER TODAY. NO MEDICAL ATTENTION WAS NEEDED. SYRINGE WAS UNUSED. DC LOT # 4282059 CATALOG# 328521 DATE OF EVENT 05.12.2025 AWAITING SAMPLE RETURNING WITH MAILING KIT 1 SYRINGE DATE OF EVENT 05.07.2025 DISCARD ¿ 1 SYRINGE FROM THIS BOX. CALLER HAS PHOTOS OF TODAY'S SYRINGE WILL SEND TO THIS CASE # THE PHOTOS UPDATE CALLER DOES NOT HAVE ABILITY TO EMAIL PHOTOS AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22161278 ↗MalfunctionJun 4, 2025Off-Label Use; Volume Accuracy Problem; Off-Label Use; Volume Accuracy Problem
PET OWNER REPORTED SEVERAL ISSUES WITH SYRINGES. STATED, "SCALE MARKINGS/LINES ARE CROOKED" STATED, SOME "SCALE MARKINGS ARE MISSING" STATED, NEEDLE IS BENT BEFORE INJECTION LOT: 4282062, 4191020, 4233018 CATALOG: 328521 DATE OF EVENT: UNKNOWN SAMPLES: NO CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143265 ↗MalfunctionJun 4, 2025Off-Label Use; Volume Accuracy Problem; Off-Label Use; Volume Accuracy Problem
PET OWNER REPORTED SEVERAL ISSUES WITH SYRINGES. STATED, "SCALE MARKINGS/LINES ARE CROOKED" STATED, SOME "SCALE MARKINGS ARE MISSING" STATED, NEEDLE IS BENT BEFORE INJECTION LOT: 4282062, 4191020, 4233018 CATALOG: 328521 DATE OF EVENT: UNKNOWN SAMPLES: NO CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143176 ↗MalfunctionMay 23, 2025Off-Label Use; Off-Label Use
PET OWNER REPORTED THE "SCALE MARKINGS" ARE "MISSING FROM BARREL BEFORE USE". STATED, 3 SYRINGES AFFECTED. LOT: 4233018. CATALOG: 328521. DATE OF EVENT: UNKNOWN. SAMPLES: YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22080925 ↗MalfunctionMay 6, 2025Off-Label Use; Off-Label Use
PET OWNER REPORTED FOUND FROM THIS BOX ABOUT 10-12 SYRINGES WITHOUT NEEDLE. FOUND AFTER REMOVING NEEDLE SHIELD. DC LOT # 4191022 CATALOG# 328521 DATE OF EVENT SAMPLE STATUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21971755 ↗MalfunctionApr 24, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
CONSUMER REPORTED FINDING THE 6MM OF RELION SYRINGES HAVE SHE 8MM LENGTH NEEDLES. NOT ALL IN THE BAG ARE LIKE THIS. BUT MOST FROM THIS BOX OF SYRINGES. LOT # 4228044 CATALOG# 328521 DATE OF EVENT UNKNOW SAMPLE STATUS AWAITING SAMPLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21901319 ↗MalfunctionMar 10, 2025Off-Label Use; Off-Label Use
PET OWNER REPORTED FOUND 1 SYRINGE THE TIP OF NEEDLE WAS HOOKED AND WOULD NOT DRAW UP INSULIN. DC. LOT # 4030019 CATALOG# 328521 DATE OF EVENT 02/12/2025 SAMPLE STATUS AWAITING SAMPLE NO REPLACEMENTS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21559425 ↗MalfunctionFeb 12, 2025Off-Label Use; Failure to Deliver; Off-Label Use; Failure to Deliver
PET OWNER REPORTED, NEEDLE WOULD NOT DRAW THE INSULIN THIS MORNING, (1 SYRINGE AFFECTED). STATED, IT HAPPENED 4 OTHER TIMES FROM THE SAME BOX BUT "DATE OF EVENT" IS "UNKNOWN" STATED, NEEDLES WERE MISSING FROM 2 SYRINGES, ("DATE OF EVENT" IS "UNKNOWN") ALL ISSUES OCCURRED FROM THE SAME BOX PET OWNER IS REPORTING. LOT: 4044041 CATALOG: 328521 DATE OF EVENT: 2025-01-21, (1 SYRINGE WOULD NOT DRAW) SAMPLES: NO CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21366091 ↗MalfunctionFeb 12, 2025Off-Label Use; Failure to Deliver; Off-Label Use; Failure to Deliver
PET OWNER REPORTED, NEEDLE WOULD NOT DRAW THE INSULIN THIS MORNING, (1 SYRINGE AFFECTED). STATED, IT HAPPENED 4 OTHER TIMES FROM THE SAME BOX BUT "DATE OF EVENT" IS "UNKNOWN" STATED, NEEDLES WERE MISSING FROM 2 SYRINGES, ("DATE OF EVENT" IS "UNKNOWN") ALL ISSUES OCCURRED FROM THE SAME BOX PET OWNER IS REPORTING. LOT: 4044041, CATALOG: 328521, DATE OF EVENT: 2025-01-21, (1 SYRINGE WOULD NOT DRAW), SAMPLES: NO CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21366002 ↗MalfunctionNov 29, 2024Off-Label Use; Failure to Deliver; Off-Label Use; Failure to Deliver
CONSUMER/PET OWNER REPORTED PLUNGER ROD DIFFICULT TO MOVE. SHE STATED THAT IT IS DIFFICULT TO INJECT AND SOMETIMES SHE HAS TO USE MULTIPLE SYRINGES. CONSUMER STATED THAT SHE DOES RE-USE. CONSUMER IS PRESENTLY USING A DIFFERENT PRODUCT AND SAID SHE WILL NO LONGER USE RELION SYRINGES. WALMART HAS ISSUED HER A REFUND FOR THE BOX. LOT #: 4071083, CATALOG #: 328521, DATE OF EVENT: UNKNOWN, SAMPLES: UNUSED SAMPLES AVAILABLE - SENDING MAIL KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20812330 ↗MalfunctionOct 9, 2024Leak/Splash; Leak/Splash
CONSUMER REPORTED: 1 SYRINGES HAD A "DULL" NEEDLE AND THE INSULIN "LEAKED" OUT WHEN HE WAS DRAWING UP. A SECOND SYRINGE FROM THE SAME PACKAGE HAD A "DULL" NEEDLE. LOT: 4058004. CATALOG: 328521. DATE OF EVENT: 2024-11-09. SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20409421 ↗MalfunctionSep 13, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
CONSUMER REPORTED, "GLOBS OF CLEAR, LIQUID SUBSTANCE" IS COMING FROM BARREL ONTO THE NEEDLE WHEN SHE DEPRESSED THE PLUNGER ROD. STATED, THIS IS PRIOR TO USE AND SHE WILL NOT USE THE SYRINGE. STATED, SHE'S FINDING THE PROBLEM WITH A LOT OF SYRINGES FROM THIS BOX AND ITS HAPPENED IN THE PAST WITH PREVIOUS BOXES, (LOTS UNKNOWN AND NUMBER OF BOXES, UNKNOWN) LOT: UNKNOWN. CATALOG: 328521. DATE OF EVENT: UNKNOWN. SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20212916 ↗MalfunctionSep 13, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
CONSUMER REPORTED, "GLOBS OF CLEAR, LIQUID SUBSTANCE" IS COMING FROM BARREL ONTO THE NEEDLE WHEN SHE DEPRESSED THE PLUNGER ROD. STATED, THIS IS PRIOR TO USE AND SHE WILL NOT USE THE SYRINGE. STATED, SHE'S FINDING THE PROBLEM WITH A LOT OF SYRINGES FROM THIS BOX AND ITS HAPPENED IN THE PAST WITH PREVIOUS BOXES, (LOTS UNKNOWN AND NUMBER OF BOXES, UNKNOWN) LOT: UNKNOWN, CATALOG: 328521, DATE OF EVENT: UNKNOWN, SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20212868 ↗MalfunctionAug 28, 2024Defective Device; Defective Device
CONSUMER REPORTED THAT ONE SYRINGE HAS A DAMAGED NEEDLE SHIELD. SHE STATED THAT THERE IS A HOLE AT THE END OF THE SHIELD. CONSUMER REPORTED ONE SYRINGE WITH A BENT NEEDLE. ALSO REPORTED ONE SYRINGE WITH NO NEEDLE. LOT #: 3352108 CATALOGS #: 328521 DATES OF EVENT: UNKNOWN SAMPLES: AVAILABLE - SENDING MAIL KIT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20086559 ↗MalfunctionAug 23, 2024Failure to Deliver; Failure to Deliver
CONSUMER REPORTED, THE NEEDLES WILL NOT DRAW THE INSULIN. STATED, 20 SYRINGES WERE AFFECTED BUT SHE CAN ONLY PROVIDE THE DATE OF EVENT FOR ONE SYRINGE. LOT: 4022023, CATALOG: UNKNOWN, DATE OF EVENT: 2024-07-29, (1 SYRINGE), 19 SYRINGES, (UNKNOWN DATE OF EVENT BUT SAME BOX), SAMPLES: YES, WAITING ON CALLBACK FOR PRODUCT NUMBER. CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20050080 ↗MalfunctionAug 23, 2024Failure to Deliver; Failure to Deliver
CONSUMER REPORTED, THE NEEDLES WILL NOT DRAW THE INSULIN. STATED, 20 SYRINGES WERE AFFECTED BUT SHE CAN ONLY PROVIDE THE DATE OF EVENT FOR ONE SYRINGE. LOT: 4022023. CATALOG: UNKNOWN. DATE OF EVENT: 2024-07-29, (1 SYRINGE). 19 SYRINGES, (UNKNOWN DATE OF EVENT BUT SAME BOX). SAMPLES: YES. WAITING ON CALLBACK FOR PRODUCT NUMBER. CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20049961 ↗MalfunctionJul 2, 2024Off-Label Use; Device Contamination with Chemical or Other Material; Off-Label Use; Device Contamination with Chemical or Other Material
PET OWNER REPORTED PUSHING "CLEAR LIQUID" FROM THE BARREL ONTO THE NEEDLE TIP BEFORE INJECTION. HE DOES NOT USE SYRINGES WITH THE "CLEAR LIQUID" FOUND. LOT: 3352108 CATALOG: 328521 DATE OF EVENT: UNKNOWN SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19656354 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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