Unifine Pentips AN 3540ACRecalls & reported problems
Owen Mumford USA Incorporated · Auto Control 1st Tier Unifine Pentips pen needles - 4mm x 32G · Class 2
All models of Unifine Pentips (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00761059354000), received between Feb 13, 2025 and Jun 30, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (2 reports).
3 other recalls cover devices cleared under the same FDA submission (K152339); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem2
- Separation Problem2
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2025Separation Problem; Separation Problem
CUSTOMER STATED SHE USED 3-4 PENTIP NEEDLES AND THEY WOULD GET STUCK TO HER SKIN WHEN TRYING TO REMOVE NEEDLE FROM THE STOMACH. ONE OF THE NEEDLES BROKE OFF IN HER STOMACH. SHE WENT TO THE HOSPITAL TO GET IT REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 22361210 ↗InjuryJun 30, 2025Separation Problem; Separation Problem
CUSTOMER STATED SHE USED 3-4 PENTIP NEEDLES AND THEY WOULD GET STUCK TO HER SKIN WHEN TRYING TO REMOVE NEEDLE FROM THE STOMACH. ONE OF THE NEEDLES BROKE OFF IN HER STOMACH. SHE WENT TO THE HOSPITAL TO GET IT REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 22361195 ↗MalfunctionFeb 13, 2025Material Integrity Problem; Material Integrity Problem
CUSTOMER STATED FROM EMAIL ON NOV 27, 2024: I HAD A DEFECTIVE PEN NEEDLE TODAY REQUIRING A VISIT TO A HOSPITAL TO GET MY INSULIN SHOT. THIS IS THE SECOND TIME, SO I AM VERY CONCERNED. WHAT CAN YOU DO ABOUT THIS ONGOING PROBLEM AS THIS THE SECOND TIME IT HAPPENED TO ME. NEEDLE PART THAT GOES INTO INSULIN TUBE WAS NOT THERE AND INSULIN COULD NOT BE INJECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21379491 ↗InjuryFeb 13, 2025Material Integrity Problem; Material Integrity Problem
CUSTOMER STATED FROM EMAIL ON (B)(6) 2024: I HAD A DEFECTIVE PEN NEEDLE TODAY REQUIRING A VISIT TO A HOSPITAL TO GET MY INSULIN SHOT. THIS IS THE SECOND TIME, SO I AM VERY CONCERNED. WHAT CAN YOU DO ABOUT THIS ONGOING PROBLEM AS THIS THE SECOND TIME IT HAPPENED TO ME. NEEDLE PART THAT GOES INTO INSULIN TUBE WAS NOT THERE AND INSULIN COULD NOT BE INJECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21379286 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K152339. One submission often covers many models, so check the product and lot details in each record.
- Z-2078-2021 · May 26, 2021 · Open, ClassifiedUnifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
- Z-0381-2018 · Nov 6, 2017 · TerminatedUnifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of d
- Z-0382-2018 · Nov 6, 2017 · TerminatedUnifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of d
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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