NovoFine® Plus 32G 185650Recalls & reported problems
Novo Nordisk Inc. · NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00301691856502), received between Dec 18, 2020 and Dec 18, 2020 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2020Break; Break
CASE DESCRIPTION: CONCERNED AN ELDERLY MALE PATIENT (AGE NOT REPORTED). NAME: NOVOFINE PLUS 32G X 4MM, BATCH NUMBER: 20B14N. MICROSCOPIC EXAMINATION PERFORMED. A VISUAL EXAMINATION OF THE BACK NEEDLE OF THE RETURNED PRODUCT WAS PERFORMED. THE NEEDLES WERE TESTED FOR FLOW WITH MEASURE THREADS. NEEDLES TESTED FOR RESISTANCE TO BREAKAGE. THE PRODUCT WAS FOUND TO BE NORMAL. THE RESULTS WERE FOUND TO COMPLY WITH SPECIFICATIONS. THE BATCH DOCUMENTATION WAS REVIEWED. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. DURING TEST IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES RELATED TO THE COMPLAINT ON THE UNUSED NEEDLES. THE BATCH DOCUMENTATION HAS BEEN REVIEWED AND FOUND TO BE NORMAL. FINAL MANUFACTURER'S COMMENT: 01-FEB-2021: FIVE SEALED NEEDLES WERE RETURNED TO NOVO NORDISK FOR EVALUATION. SINCE NO FAULTS WERE FOUND ON THE RETURNED NOVOFINE NEEDLES AND ONLY VERY LIMITED INFORMATION REGARDING THE PATIENTS HANDLING OF THE SUSPECTED DEVICE IS REPORTED IN THE CASE, IT IS NOT POSSIBLE TO ELUCIDATE A CLEAR ROOT CAUSE FOR THE EXPERIENCED ADVERSE EVENT AND THUS NOT POSSIBLE TO FIND SIMILAR INCIDENTS TO THE ONE REPORTED IN ARGUS CASE (B)(4). CONSIDERING THE NATURE OF THE EVEN
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 11039558 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page