Pen NeedleRecalls & reported problems across all models
Wal-Mart Stores, Inc. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 139
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 3 models of Pen Needle by Wal-Mart Stores, Inc. in the FDA's device registry (GUDID). Together they are named in 139 adverse event reports in the FDA's MAUDE database, received between Mar 26, 2021 and Sep 30, 2026 — classified as 1 injury, 138 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (76 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Pen Needle problems
Device problems
- Failure to Deliver76
- Off-Label Use29
- Device Markings/Labelling Problem21
- Misconnection15
- Break9
- Defective Device8
- Complete Blockage5
- Material Protrusion/Extrusion3
Patient problems
- No Clinical Signs, Symptoms or Conditions138
- Hyperglycemia2
- Needle Stick/Puncture1
- Pain1
Pen Needle models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Pen Needle 320618Needle, hypodermic, single lumen60 reports
- Pen Needle 681131386807Needle, hypodermic, single lumen40 reports
- Pen Needle 320616Needle, hypodermic, single lumen39 reports
Recent Pen Needle adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Wal-Mart Stores, Inc. products
All Wal-Mart Stores, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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