Unifine PentipsRecalls & reported problems across all models

We found 5 models of Unifine Pentips by Owen Mumford USA Incorporated in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2019 and Jun 30, 2025 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

2 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Unifine Pentips recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 6, 2017Terminated

   Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.

   Z-0382-2018 · Root cause: Environmental control · Recall details · FDA record ↗

2. Nov 6, 2017Terminated

   Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.

   Z-0381-2018 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported Unifine Pentips problems

Unifine Pentips models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Unifine Pentips AN 3550

  Needle, Hypodermic, Single Lumen
  1 recall2 reports
• Unifine Pentips AN 1150

  Needle, Hypodermic, Single Lumen
  1 recall0 reports
• Unifine Pentips AN 3540AC

  Needle, Hypodermic, Single Lumen
  4 reports
• Unifine Pentips AN 3530

  Needle, Hypodermic, Single Lumen
  3 reports
• Unifine Pentips AN 3590

  Needle, Hypodermic, Single Lumen
  1 report

Recent Unifine Pentips adverse event reports

The 10 most recent reports across all models, 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 ↗
• InjuryAug 23, 2024Use of Device Problem; Use of Device Problem

  WHEN A NEW NEEDLE IS OPENED, THE NEEDLE IS EXPOSED OUTSIDE OF THE NEEDLE CAP, AND PRICKED THE USER'S (NURSE) FINGER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20057908 ↗
• InjuryAug 23, 2024Nonstandard Device; Manufacturing, Packaging or Shipping Problem; Nonstandard Device; Manufacturing, Packaging or Shipping Problem

  WHEN A NEW NEEDLE WAS OPENED, THE NEEDLE WAS EXPOSED OUTSIDEOF THE NEEDLE CAP AND IT PRICKED THE USER'S (NURSE) FINGER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20046785 ↗
• 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 ↗
• InjuryAug 25, 2020Off-Label Use; Detachment of Device or Device Component; Off-Label Use; Detachment of Device or Device Component

  PATIENT'S MOTHER CALLED IN ON (B)(6) 2020 TO REPORT THAT THE NIGHT BEFORE WHEN SHE INJECTED HER SON USING OM 31G 6MM LOT 1909755, THE PEN NEEDLE BROKE OFF INTO THE PATIENT'S LEG. SHE REPORTED THEY TOOK HIM AND THE PEN NEEDLE TO THE EMERGENCY ROOM AND THAT THE HUB WAS LEFT AT HE EMERGENCY DEPARTMENT. SHE REPORTED THAT SHE HAS A ZOOM CONSULT WITH A SURGEON TO DETERMINE IF ANY OTHER ACTIONS ARE NECESSARY. FOLLOW UP WITH THE PATIENT'S MOTHER INDICATED THE DOCTOR SAID THEY WOULD JUST HAVE TO WAIT FOR THE NEEDLE TO COME OUT ON ITS OWN. THE PATIENT'S MOTHER REPORTED SHE WAS INJECTING A GROWTH HORMONE, GENTROPIN. THE IFU FOR GENTROPIN INSTRUCTS THE USERS TO ONLY USE 29G, 30G OR 31G PEN NEEDLES MANUFACTURED BY BECKTON DICKSON. OWEN MUMFORD HAS NOT TESTED GENTROPIN WITH OM PEN NEEDLES AND THERE IS A COMPATIBILITY CHART INCLUDED ON THE PACKAGING WITH DRUGS AND PENS THAT OM HAS TESTED AND CLAIMS COMPATIBILITY WITH. GENTROPIN IS NOT LISTED HERE.

  Patient problems: Anxiety; No Known Impact Or Consequence To Patient

  MAUDE report 10448327 ↗
• 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 ↗