Pen Needle 320616Recalls & reported problems
Wal-Mart Stores, Inc. · ReliOn Pen Needles 8mm x 31 Gauge (5/16" x 0.25mm) Pen Needles 50 count · Class 2
All models of Pen Needle (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00681131386814), received between Feb 3, 2022 and Sep 30, 2026 — classified as 39 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (32 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Deliver32
- Off-Label Use27
- Complete Blockage2
- Break1
- Defective Device1
- Detachment of Device or Device Component1
- Leak/Splash1
- Material Protrusion/Extrusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- Hyperglycemia1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949159 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949041 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948960 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948862 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948656 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Dog pet owner Reported used about 25 pen needles from this box and realized Dog was not getting his insulin. does not complete a flow check. Dog went into Ketoacidosis. Had medical attention and is fine now. caller has the pen needles. sending mailing kit.--dog was in hospital for 2 days about a month ago with IV fluids and another medication to help dog eat food. They increased insulin dose from 2 units twice a day to 4 units twice a day. Dog weight is 15lbs. DC.Lot # 2279565.Catalog# 320616 Relion Pen needle.Date of Event Unknown.Sample Status Awaiting sample.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948546 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Dog pet owner Reported used about 25 pen needles from this box and realized Dog was not getting his insulin. does not complete a flow check. Dog went into Ketoacidosis. Had medical attention and is fine now. caller has the pen needles. sending mailing kit.--dog was in hospital for 2 days about a month ago with IV fluids and another medication to help dog eat food. They increased insulin dose from 2 units twice a day to 4 units twice a day. Dog weight is 15lbs. DC.Lot # 2279565.Catalog# 320616 Relion Pen needle.Date of Event Unknown.Sample Status Awaiting sample.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948368 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Dog pet owner Reported used about 25 pen needles from this box and realized Dog was not getting his insulin. does not complete a flow check. Dog went into Ketoacidosis. Had medical attention and is fine now. caller has the pen needles. sending mailing kit.--dog was in hospital for 2 days about a month ago with IV fluids and another medication to help dog eat food. They increased insulin dose from 2 units twice a day to 4 units twice a day. Dog weight is 15lbs. DCLot # 2279565Catalog# 320616 Relion Pen needleDate of Event UnknownSample Status Awaiting sample.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946290 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Dog pet owner Reported used about 25 pen needles from this box and realized Dog was not getting his insulin. does not complete a flow check. Dog went into Ketoacidosis. Had medical attention and is fine now. caller has the pen needles. sending mailing kit.--dog was in hospital for 2 days about a month ago with IV fluids and another medication to help dog eat food. They increased insulin dose from 2 units twice a day to 4 units twice a day. Dog weight is 15lbs. DCLot # 2279565Catalog# 320616 Relion Pen needleDate of Event UnknownSample Status Awaiting sample
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946230 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946070 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Dog pet owner Reported used about 25 pen needles from this box and realized Dog was not getting his insulin. does not complete a flow check. Dog went into Ketoacidosis. Had medical attention and is fine now. caller has the pen needles. sending mailing kit.--dog was in hospital for 2 days about a month ago with IV fluids and another medication to help dog eat food. They increased insulin dose from 2 units twice a day to 4 units twice a day. Dog weight is 15lbs. DCLot # 2279565Catalog# 320616 Relion Pen needleDate of Event UnknownSample Status Awaiting sample
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945950 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Dog pet owner Reported used about 25 pen needles from this box and realized Dog was not getting his insulin. does not complete a flow check. Dog went into Ketoacidosis. Had medical attention and is fine now. caller has the pen needles. sending mailing kit.--dog was in hospital for 2 days about a month ago with IV fluids and another medication to help dog eat food. They increased insulin dose from 2 units twice a day to 4 units twice a day. Dog weight is 15lbs. DCLot # 2279565Catalog# 320616 Relion Pen needleDate of Event UnknownSample Status Awaiting sample
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945785 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Dog pet owner Reported used about 25 pen needles from this box and realized Dog was not getting his insulin. does not complete a flow check. Dog went into Ketoacidosis. Had medical attention and is fine now. caller has the pen needles. sending mailing kit.--dog was in hospital for 2 days about a month ago with IV fluids and another medication to help dog eat food. They increased insulin dose from 2 units twice a day to 4 units twice a day. Dog weight is 15lbs. DCLot #: 2279565.Catalog #: 320616 Relion Pen needle.Date of Event: Unknown.Sample Status: Awaiting sample.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945286 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945236 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Dog pet owner Reported used about 25 pen needles from this box and realized Dog was not getting his insulin. does not complete a flow check. Dog went into Ketoacidosis. Had medical attention and is fine now. caller has the pen needles. sending mailing kit.--dog was in hospital for 2 days about a month ago with IV fluids and another medication to help dog eat food. They increased insulin dose from 2 units twice a day to 4 units twice a day. Dog weight is 15lbs. DCLot # 2279565Catalog# 320616 Relion Pen needleDate of Event UnknownSample Status Awaiting sample.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944860 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944787 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944423 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Dog pet owner Reported used about 25 pen needles from this box and realized Dog was not getting his insulin. does not complete a flow check. Dog went into Ketoacidosis. Had medical attention and is fine now. caller has the pen needles. sending mailing kit.Dog was in hospital for 2 days about a month ago with IV fluids and another medication to help dog eat food. They increased insulin dose from 2 units twice a day to 4 units twice a day. Dog weight is 15lbs. DCLot # 2279565Catalog# 320616 Relion Pen needleDate of Event UnknownSample Status Awaiting sample
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944358 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Dog pet owner Reported used about 25 pen needles from this box and realized Dog was not getting his insulin. does not complete a flow check. Dog went into Ketoacidosis. Had medical attention and is fine now. caller has the pen needles. sending mailing kit.--dog was in hospital for 2 days about a month ago with IV fluids and another medication to help dog eat food. They increased insulin dose from 2 units twice a day to 4 units twice a day. Dog weight is 15lbs. DCLot # 2279565Catalog# 320616 Relion Pen needleDate of Event UnknownSample Status Awaiting sample.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944174 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Dog pet owner Reported used about 25 pen needles from this box and realized Dog was not getting his insulin. does not complete a flow check. Dog went into Ketoacidosis. Had medical attention and is fine now. caller has the pen needles. sending mailing kit.--dog was in hospital for 2 days about a month ago with IV fluids and another medication to help dog eat food. They increased insulin dose from 2 units twice a day to 4 units twice a day. Dog weight is 15lbs. DCLot # 2279565Catalog# 320616 Relion Pen needleDate of Event UnknownSample Status Awaiting sample.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944020 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Dog pet owner Reported used about 25 pen needles from this box and realized Dog was not getting his insulin. does not complete a flow check. Dog went into Ketoacidosis. Had medical attention and is fine now. caller has the pen needles. sending mailing kit.--dog was in hospital for 2 days about a month ago with IV fluids and another medication to help dog eat food. They increased insulin dose from 2 units twice a day to 4 units twice a day. Dog weight is 15lbs. DCLot # 2279565Catalog# 320616 Relion Pen needleDate of Event UnknownSample Status Awaiting sample.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943938 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943884 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943681 ↗MalfunctionSep 30, 2026Off-Label Use; Failure to Deliver
Dog pet owner Reported used about 25 pen needles from this box and realized Dog was not getting his insulin. does not complete a flow check. Dog went into Ketoacidosis. Had medical attention and is fine now. caller has the pen needles. sending mailing kit.--dog was in hospital for 2 days about a month ago with IV fluids and another medication to help dog eat food. They increased insulin dose from 2 units twice a day to 4 units twice a day. Dog weight is 15lbs. DCLot # 2279565Catalog# 320616 Relion Pen needleDate of Event UnknownSample Status Awaiting sample
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943521 ↗MalfunctionJul 17, 2025Off-Label Use; Failure to Deliver; Off-Label Use; Failure to Deliver
CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, SHE STATED THAT THERE IS NO INSULIN FLOW. CONSUMER DOES NOT PRIME. LOT #: 3313014 CATALOG #: 320616 DATE OF EVENT: UNKNOWN SAMPLES: DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22535744 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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