NovoFine® Plus 32G 185591Recalls & 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 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00301691855918), received between Jul 9, 2020 and Aug 6, 2020 — classified as 2 injuries.
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
- Device Handling Problem1
- Material Twisted/Bent1
Patient problems
- Administration Site Reaction1
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent
NEEDLE BROKE OFF IN THE PATIENT'S SKIN [NEEDLE ISSUE] NEEDLE BROKE OFF IN THE PATIENT'S SKIN AND STUCK IN THE SKIN [INJURY ASSOCIATED WITH DEVICE] INJECTION SITE SWOLLEN, BLEB UNDER THE SKIN WHICH WAS THE LOCALIZED SWELLING [INJECTION SITE SWELLING] BENDING OF THE NEEDLE SIDEWAYS DURING INJECTION [NEEDLE ISSUE] INJECTION SITE IS RED [INJECTION SITE ERYTHEMA] MEDIATION RAN DOWN HIS SKIN DUE TO NEEDLE BROKE OFF [INJECTION SITE EXTRAVASATION] BENDING OF THE NEEDLE SIDEWAYS DURING INJECTION IS WHAT CAUSED SCRATCHES [INJECTION SITE STREAKING] PARTIAL DOSE RECEIVED DUE TO NEEDLE BROKE OFF [INCORRECT DOSE ADMINISTERED BY DEVICE] CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A MEDICAL DOCTOR AS "NEEDLE BROKE OFF IN THE PATIENT'S SKIN(NEEDLE BROKEN)" BEGINNING ON (B)(6)2020, "NEEDLE BROKE OFF IN THE PATIENT'S SKIN AND STUCK IN THE SKIN(NEEDLE INJURY)" BEGINNING ON (B)(6) 2020, "INJECTION SITE SWOLLEN, BLEB UNDER THE SKIN WHICH WAS THE LOCALIZED SWELLING(INJECTION SITE SWELLING)" BEGINNING ON (B)(6) 2020, "BENDING OF THE NEEDLE SIDEWAYS DURING INJECTION(NEEDLE BENT)" BEGINNING ON (B)(6) 2020, "INJECTION SITE IS RED(INJECTION SITE REDNESS)" BEGINNING O
Patient problems: Administration Site Reaction; Device Embedded In Tissue or Plaque; Injury
MAUDE report 10374118 ↗InjuryJul 9, 2020Device Handling Problem; Device Handling Problem
CASE DESCRIPTION: INVESTIGATION RESULT: NAME: NOVOFINE PLUS 32G X 4MM - BATCH 19F02N. THE BATCH DOCUMENTATION WAS REVIEWED. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. THE BATCH DOCUMENTATION HAS BEEN REVIEWED AND FOUND TO BE NORMAL. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. SINCE LAST SUBMISSION THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: INVESTIGATION RESULTS UPDATED. COMPANY COMMENT UPDATED NARRATIVE UPDATED ACCORDINGLY. COMPANY COMMENT: (B)(6) 2020: THE SUSPECTED DEVICE HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. THE BATCH DOCUMENTATION WAS REVIEWED. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. THE ELDERLY AGE OF THE PATIENT (69 YEARS) IS A SIGNIFICANT RISK FACTOR FOR PRODUCT APPEARANCE CONFUSION AND INGESTION OF NEEDLE BY MISTAKE. RELEVANT INFORMATION ON VISUAL ACUITY, TRAINING ON NEEDLE USAGE, AND CONCOMITANT MEDICATIONS WHICH LOOK LIKE NOVOFINE NEEDLES ARE UNAVAILABLE FOR COMPLETE CAUSALITY ASSESSMENT. IT COULD BE AN ACCIDENTAL INCIDENT. H3 CONTINUED: EVALUATION SUMMARY. NAME: NOVOFINE PLUS 32G X 4MM - BATCH 19F02N. THE BATCH DOCUMENTATION WAS REVIEWED. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. THE BATCH
Patient problems: Foreign Body In Patient
MAUDE report 10255307 ↗
Other Needle, Hypodermic, Single Lumen devices
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- 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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