Unifine Pentips AN 3530Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00384703530010), received between Dec 20, 2019 and Jan 21, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT CALLED TO STATE SHE WAS INJECTING HER INSULIN AND WHEN SHE FINISHED, SHE PULLED OUT THE PEN AND THAT THE NEEDLE WAS NOT ATTACHED.

  Patient problems: Anxiety

  MAUDE report 11208020 ↗
• MalfunctionJan 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT CALLED IN TO OUR US OFFICE TO REPORT THAT WHILE GIVING HERSELF HER INSULIN SHOT, WHEN SHE PULLED THE PEN OUT THE NEEDLE WAS MISSING.

  Patient problems: Anxiety

  MAUDE report 11197515 ↗
• InjuryDec 20, 2019Material Separation; Material Separation

  CUSTOMER CALLED IN TO LET US KNOW THAT SHE HAD GIVEN HERSELF AN INJECTION AND WHEN SHE WENT TO REMOVE THE NEEDLE FROM HER SKIN, THE NEEDLE REMAINED IN HER SKIN. SHE WENT TO THE EMERGENCY ROOM WHERE THEY DID A SONOGRAM AND LOCATED THE NEEDLE, HOWEVER, WOULD NOT ATTEMPT TO REMOVE THE NEEDLE. THE ER ADVISED HER TO WAIT AND SEE IF IT EXPELLED ITSELF BECAUSE GOING TO REMOVE IT SURGICALLY WOULD CAUSE MORE DAMAGE TO HER. THE PATIENT ADMITTED TO USING HER PEN NEEDLES 2-3 TIMES BEFORE CHANGING THE NEEDLE, IN SPITE OF INSTRUCTIONS TO USE THE NEEDLE ONLY ONE TIME. SHE WAS INSTRUCTED AGAIN TO FOLLOW THE INSTRUCTIONS, TO USE THE PEN NEEDLES ONE TIME AND DISCARD IN A SHARPS CONTAINER.

  Patient problems: Discomfort; Distress

  MAUDE report 9507180 ↗

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