Unifine Pentips Plus AN 3840Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00384703840010), received between Nov 15, 2022 and Sep 24, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Separation Problem” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Separation Problem

  Customer stated her pentip needles are bending when doing her injections and on one of them when she removed the neede from the injection site, the needle was not there. It appeared to be broken off, but she is unsure if the needle is still in her skin or not. After following up again, she indicated she did not go the dr and she is fine.

  Patient problems: Foreign Body In Patient

  MAUDE report 50889509 ↗
• InjurySep 24, 2026Separation Problem

  Patient problems: Foreign Body In Patient

  MAUDE report 50889508 ↗
• InjuryAug 23, 2024Separation Problem; Separation Problem

  CUSTOMER STATED HE WAS USING OUR 4MM X 32G PENTIP NEEDLE FOR HIS INJECTION AND THE NEEDLE GOT STUCK IN HIS RIGHT LEG 3 WEEKS AGO. THE CUSTOMER WENT TO THE DOCOTRO TO GET A X-RAY AND ULTRASOUND DONE ON HIS LEG. THE DOCTOR REPORTED THERE WAS NO NEEDLE FOUND IN HIS LEG. CUSTOMER CALLED OM TO SEEK ADDITIONAL INFORMATION ABOUT HOW TO REMOVE THE NEEDLE FROM HIS LEG. HE WAS ADVISED TO GO BACK TO SEE HIS DOCTOR.

  Patient problems: Foreign Body In Patient

  MAUDE report 20056294 ↗
• InjuryAug 23, 2024Separation Problem; Separation Problem

  CUSTOMER STATED HE WAS USING OUR 4MM X 32G PENTIP NEEDLE FOR HIS INJECTION AND THE NEEDLE GOT STUCK IN HIS RIGHT LEG 3 WKS AGO. THE CUSTOMER WENT TO THE DOCTOR TO GET A X-RAY AND ULTRASOUND DONE ON HIS LEG. THE DOCTOR REPORTED THERE WAS NO NEEDLE FOUND IN HIS LEG. CUSTOMER CALLED OM TO SEEK ADDITIONAL INFORMATION ABOUT HOW TO REMOVE THE NEEDLE FROM HIS LEG. HE WAS ADVISED TO GO BACK TO SEE HIS DOCTOR.

  Patient problems: Foreign Body In Patient

  MAUDE report 20056271 ↗
• MalfunctionNov 15, 2022Separation Problem; Separation Problem

  PATIENT CALLED US OFFICE TO LET THEM KNOW THAT SHE IS HAVING ISSUES PUTTING THE PEN NEEDLES STRAIGHT ON HER INSULIN PEN. SHE STATED WITH THE LAST INJECTION THE PEN NEEDLE BROKE OFF IN HER STOMACH.

  Patient problems: Foreign Body In Patient

  MAUDE report 15801539 ↗
• InjuryNov 15, 2022Separation Problem; Separation Problem

  PATIENT CALLED TO LET US KNOW THAT SHE IS HAVING ISSUES PUTTING THE PEN NEEDLES STRAIGHT ON HER INSULIN PEN. SHE STATED WITH THE LAST INJECTION THE PEN NEEDLE BROKE OFF IN HER STOMACH.

  Patient problems: Foreign Body In Patient

  MAUDE report 15801529 ↗

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, Classified
  Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
• Z-0382-2018 · Nov 6, 2017 · Terminated
  Unifine 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
• Z-0381-2018 · Nov 6, 2017 · Terminated
  Unifine 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