Ahold - CareOne UPP 5mm pen needles AN 3850AHRecalls & reported problems
Ahold U.S.A., Inc. · For use with injectors for the subcutaneous injection of approved drugs, including insulin · 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 00041520035363), received between Dec 21, 2023 and Dec 21, 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. 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
- 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.
InjuryDec 21, 2023Separation Problem; Separation Problem
OWEN MUMFORD'S DISTRIBUTOR RECEIVED A LETTER FROM ONE OF THEIR PATIENTS STATING SHE HAD TWO BOXES OF THEIR PRIVATE LABELED PEN NEEDLES, UNIFINE PENTIPS PLUS AND A NEEDLE FROM EACH BOX BROKE OFF IN HER ABDOMENT. SHE REPORTED IN THE LETTER TO THEM THAT SHE WAS ABLE TO REMOVE ONE HERSELF, BUT HAD TO GO GET AN X-RAY TO SEE IF THE OTHER COULD BE FOUND, BUT IT COULD NOT BE LOCATED.
Patient problems: Foreign Body In Patient
MAUDE report 18373740 ↗InjuryDec 21, 2023Separation Problem; Separation Problem
OWEN MUMFORD USA INC'S DISTRIBUTOR RECEIVED A LETTER FROM ONE OF THEIR PATIENTS STATING SHE HAD TWO BOXES OF THEIR PRIVATE LABELED PEN NEEDLES, UNIFINE PENTIPS PLUS AND A NEEDLE FROM EACH BOX BROKE OFF IN HER ABDOMEN. SHE REPORTED IN THE LETTER TO THEM THAT SHE WAS ABLE TO REMOVE ONE HERSELF, BUT HAD TO GO GET AN X-RAY TO SEE IF THE OTHER COULD BE FOUND, BUT IT COULD NOT BE LOCATED.
Patient problems: Foreign Body In Patient
MAUDE report 18373705 ↗
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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