Assure® ID Safety Pen Needle 5mm x 31g 100's 275131Recalls & reported problems
Arkray USA, Inc. · Insulin Safety Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00015482275310), received between Sep 25, 2019 and Sep 25, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
- Protective Measures Problem1
Patient problems
- Exposure to Body Fluids1
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2019Break; Protective Measures Problem
THE INCIDENT WITH THE NEEDLESTICK DID NOT HAPPEN WITH THE REPORTER, IT HAPPENED WITH ANOTHER NURSE IN THE FACILITY. AS FAR AS THE REPORTER IS AWARE, THE DEVICE APPEARED TO BE IN GOOD CONDITION PRIOR TO USE. WHEN REMOVING THE NEEDLE FROM THE INSULIN PEN, THE DEVICE FELL APART AND THE NEEDLE WAS EXPOSED, AND THE SPRING WAS STILL AROUND THE NEEDLE AND THE NURSE WHO WAS ADMINISTERING THE INSULIN WAS STUCK TWICE IN THE FINGER WITH THE EXPOSED NEEDLE. THE REPORTER SAID THE PT WHO WAS ADMINISTERED THE INSULIN DID NOT HAVE ANY KNOWN INFECTIOUS DISEASES. THE NURSE WHO WAS STUCK WITH THE NEEDLE CLEANED THE AREA THOROUGHLY WITH SOAP AND WATER AND ALCOHOL. THE NURSE WAS SENT TO ANOTHER LOCATION WITHIN THE PARENT COMPANY TO HAVE BLOODWORK DONE TO TEST FOR ANY INFECTIOUS DISEASES. HER BLOODWORK REPORT CAME BACK AS BEING NEGATIVE FOR ANY INFECTIOUS DISEASE. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Exposure to Body Fluids; Needle Stick/Puncture
MAUDE report 9124394 ↗
Other Needle, Hypodermic, Single Lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
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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