LEADER 4938494Recalls & reported problems
Cardinal Health 110, Inc. · LDR Unifine Pentips Plus Micro 32G x 4mm 100 pen needles · Class 2
- 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 00096295125597), received between Jan 27, 2023 and Jan 27, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Separation 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Separation Problem2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2023Separation Problem; Separation Problem
PATIENT CALLED THE US OFFICE (IMPORTER) ON (B)(6) 2022 TO REPORT THAT A PEN NEEDLE GOT STUCK IN HER LEG, BUT THAT SHE WAS ABLE TO REMOVE IT HERSELF. SHE ALSO COMPLAINED THAT ANOTHER NEEDLE WAS ALREADY BENT AND WAS NOT ABLE TO GIVE HERSELF AN INJECTION WITH IT.
Patient problems: Foreign Body In Patient
MAUDE report 16253110 ↗InjuryJan 27, 2023Separation Problem; Separation Problem
PATIENT CALLED IN ON (B)(6) 2022 TO REPORT THAT A PEN NEEDLE GOT STUCK IN HER LEG, BUT THAT SHE WAS ABLE TO REMOVE IT HERSELF. SHE ALSO COMPLAINED THAT ANOTHER NEEDLE WAS ALREADY BENT AND WAS NOT ABLE TO GIVE HERSELF AN INJECTION WITH IT.
Patient problems: Foreign Body In Patient
MAUDE report 16253104 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.