Insulin Syringes, 1/2mL 31G x 8MM 328509Recalls & reported problems
Wal-Mart Stores, Inc. · ReliOn Insulin Syringes 1/2mL 31 Gauge, 8mm (5/16") U-100 100count · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This ReliOn insulin syringe is used to inject insulin. Many reports describe insulin leaking from the barrel, syringes with missing scale markings, and parts breaking or separating. The 157 reports include no deaths and 3 injuries. 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
- 169
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 169 adverse event reports that list this exact device (DI 00681131311762), received between Nov 27, 2017 and Sep 29, 2026 — classified as 3 injuries, 166 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (57 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/Splash57
- Device Markings/Labelling Problem22
- Break16
- Device Contamination with Chemical or Other Material15
- Failure to Deliver13
- Material Separation11
- Defective Device9
- Volume Accuracy Problem8
Patient problems
- No Known Impact Or Consequence To Patient71
- No Clinical Signs, Symptoms or Conditions61
- No Consequences Or Impact To Patient31
- No Patient Involvement3
- Foreign Body In Patient2
- No Information2
- Burning Sensation1
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 25 most recent of 169 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Device Markings/Labelling Problem
Pharmacist reported issue on consumers behalf.Stated, there were 15 syringes without scale markings prior to injection.Stated, consumer discarded samplesStated, pharmacy replaced box.Lot: 3352058Catalog: 328509Date of Event: UnknownSamples: No CL.___________________________________________________________________________________________________________________________________________________This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken fourteen additional complaint records were created for Scale Marking Missing. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929561 ↗MalfunctionSep 29, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929461 ↗MalfunctionSep 29, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929206 ↗MalfunctionSep 29, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929086 ↗MalfunctionSep 29, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929019 ↗MalfunctionSep 29, 2026Device Markings/Labelling Problem
Pharmacist reported issue on consumers behalf.Stated, there were 15 syringes without scale markings prior to injection.Stated, consumer discarded samples.Stated, pharmacy replaced box.Lot: 3352058.Catalog: 328509.Date of Event: Unknown.Samples: No CL.___________________________________________________________________________________________________________________________________________________This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken fourteen additional complaint records were created for Scale Marking Missing. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. (b)(6) 14-September-2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928955 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Pharmacist reported issue on consumers behalf.Stated, there were 15 syringes without scale markings prior to injection.Stated, consumer discarded samples.Stated, pharmacy replaced box.Lot: 3352058.Catalog: 328509.Date of Event: Unknown.Samples: No CL.This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken fourteen additional complaint records were created for Scale Marking Missing. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. (b)(6), 14-September-2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916614 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916428 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916345 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Pharmacist reported issue on consumers behalf.Stated, there were 15 syringes without scale markings prior to injection.Stated, consumer discarded samplesStated, pharmacy replaced box.Lot: 3352058Catalog: 328509Date of Event: UnknownSamples: No CLThis intake record was reviewed as part of CAPAs #(b)(4) and #(b)(4) and deficiencies were identified. The following actions were taken fourteen additional complaint records were created for Scale Marking Missing. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. (b)(6) 14-September-2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916131 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Pharmacist reported issue on consumers behalf.Stated, there were 15 syringes without scale markings prior to injection.Stated, consumer discarded samplesStated, pharmacy replaced box.Lot: 3352058Catalog: 328509Date of Event: UnknownSamples: No CL.This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken fourteen additional complaint records were created for Scale Marking Missing. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available. (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915867 ↗MalfunctionSep 28, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915544 ↗MalfunctionMay 13, 2025Leak/Splash; Defective Device; Leak/Splash; Defective Device
CONSUMER STATED THAT THE BARREL TO THE SYRINGE WAS LEAKING OUT INSULIN BECAUSE IT APPEARED TO BE CUT/DAMAGED. LOT: 4036087. CATALOG: 328509. DATE OF EVENT: 2025-17-04. SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22009509 ↗MalfunctionDec 10, 2024Leak/Splash; Leak/Splash
CONSUMER REPORTED THAT SEVERAL OF THE NEEDLE HUBS SEPARATED INSIDE OF THE SHIELD. LOT #: 4036087. CATALOG #: 328509. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20894020 ↗MalfunctionNov 20, 2024Volume Accuracy Problem; Volume Accuracy Problem
PHARMACIST CALLED ON CONSUMER'S BEHALF TO REPORT SCALE PRINT MISSING FROM SEVERAL SYRINGES FROM ONE BOX. PHARMACIST REPLACED THE BOX TO THE CONSUMER. LOT#: 3352058, CATALOG#: 328509, DATE OF EVENT: UNKNOWN, SAMPLES: AVAILABLE - SENDING MAIL KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20735487 ↗MalfunctionNov 18, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
CONSUMER REPORTED HE IS FINDING A LIQUID INSIDE SOME OF SYRINGES. DISCARDED THE RELION SAMPLES. LOT # 328509, CATALOG# 4071080, DATE OF EVENT UNKNOWN, SAMPLE STATUS DISCARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20707549 ↗MalfunctionSep 16, 2024Volume Accuracy Problem; Volume Accuracy Problem
CONSUMER REPORTED FINDING 4 SYRINGES WITH "MISSING SCALE MARKINGS" FROM THE BARREL PRIOR TO USE. LOT: 3352058 CATALOGS: 328509 DATES OF EVENT: UNKNOWN SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20230140 ↗MalfunctionAug 22, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
PHARMACIST REPORTED ISSUE ON CONSUMERS BEHALF. STATED, THERE WERE 15 SYRINGES WITHOUT SCALE MARKINGS PRIOR TO INJECTION. STATED, CONSUMER DISCARDED SAMPLES. STATED, PHARMACY REPLACED BOX. LOT: 3352058. CATALOG: 328509. DATE OF EVENT: UNKNOWN. SAMPLES: NO CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20030887 ↗MalfunctionAug 21, 2024Volume Accuracy Problem; Volume Accuracy Problem
SPOUSE OF CONSUMER REPORTED SCALE MARKINGS ARE MISSING FROM 6 SYRINGES. LOT #: 3352058. CATALOG #: 328509. DATE OF EVENT: SAMPLES: AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20019989 ↗MalfunctionJul 25, 2024Volume Accuracy Problem; Volume Accuracy Problem
CONSUMER REPORTED PRIOR TO INJECTION, THE "SCALE MARKINGS" WERE "MISSING". FROM THE BARREL. 1 SYRINGE AFFECTED ON (B)(6) 2024. 3 SYRINGES AFFECTED ON (B)(6) 2024. 4 SYRINGES IN TOTAL WITH DIFFERENT INCIDENT DATES. THEY CAME FROM THE SAME BOX. LOT: 3352058 CATALOG: 328509. DATE OF EVENT: 2024-07-03. SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19827717 ↗MalfunctionJul 25, 2024Volume Accuracy Problem; Volume Accuracy Problem
CONSUMER REPORTED PRIOR TO INJECTION, THE "SCALE MARKINGS" WERE "MISSING". FROM THE BARREL. 1 SYRINGE AFFECTED ON 2024-06-29 3 SYRINGES AFFECTED ON 2024-07-03 4 SYRINGES IN TOTAL WITH DIFFERENT INCIDENT DATES. THEY CAME FROM THE SAME BOX. LOT: 3352058 CATALOG: 328509 DATE OF EVENT: 2024-07-03 SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19827701 ↗MalfunctionApr 19, 2024Leak/Splash; Leak/Splash
CONSUMER REPORTED NEEDLE HUB SEPARATED INSIDE OF THE SHIELD. LOT #: 3198219, CATALOG #: 328509, DATE OF EVENT: 03-26-24, SAMPLES: AVAILABLE - SENDING MAIL KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19147683 ↗MalfunctionMar 8, 2024Leak/Splash; Leak/Splash
ADULT CHILD OF CONSUMER REPORTED NEEDLE HUB SEPARATED INSIDE OF THE SHIELD. NEEDLES BEND WHILE REMOVING SHIELD. NEEDLE SHIELD DIFFICULT TO REMOVE. LOT #: 3198219 CATALOG #: 328509 DATE OF EVENT: UNKNOWN SAMPLES: AVAILABLE - SENDING MAIL KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18870315 ↗MalfunctionMar 6, 2024Failure to Deliver; Failure to Deliver
CONSUMER REPORTED SHE WAS NOT ABLE TO DRAW INSULIN. STATED, SHE SAW A "AIR BUBBLE" INSIDE THE BARREL WHEN TRYING TO DRAW. LOT: 3156431, CATALOG: 328509, DATE OF EVENT: UNKNOWN, SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18847295 ↗MalfunctionJan 24, 2024Material Separation; Material Separation
CONSUMER REPORTED WHEN SHE REMOVED THE NEEDLE SHIELD, THE NEEDLE AND HUB SEPARATED AND IS STUCK INSIDE THE NEEDLE SHIELD. STATED, THERE IS NO EXPIRATION DATE ON THE BAG SHE'S USING AND DOES NOT KNOW HOW OLD THE SYRINGES ARE. 1 SYRINGE AFFECTED. LOT: 0083446. CATALOG: 328509. DATE OF EVENT: 2023-12-26. SAMPLE: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18570719 ↗
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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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