Unistik 3 AT1014Recalls & reported problems
Owen Mumford Limited · Unistik 3 Extra - 21G x 2.0mm - 200 count - sterile, single use safety lancet · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00384701014017), received between Oct 12, 2018 and Oct 11, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (2 reports).
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
- Retraction Problem2
- Fail-Safe Did Not Operate1
- Fail-Safe Problem1
- Protective Measures Problem1
Patient problems
- Needle Stick/Puncture2
- No Clinical Signs, Symptoms or Conditions2
- Anxiety1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2024Retraction Problem; Retraction Problem
PCT WAS GIVING PATIENT BLOOD SUGAR CHECK AND WHEN GOING TO PUT THE LANCET IN THE SHARPS CONTAINER THE NEEDLE WOULD NOT RETRACT AND STUCK PCT'S FINGER. NURSE MANAGER PUT LANCET IN SPECIMEN CONTAINER AND THE NEEDLE DID EVENTUALLY RETRACT WITH SOME MOVEMENT. IT APPEARS THERE WAS AN ISSUE WITH THE SAFETY MECHANISM. THE PCT CLEANED THE SITE AND DID NOT NEED CARE.
Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions
MAUDE report 20431112 ↗MalfunctionOct 11, 2024Retraction Problem; Retraction Problem
PCT WAS GIVING PATIENT BLOOD SUGAR CHECK AND WHEN GOING TO PUT THE LANCET IN THE SHARPS CONTAINER THE NEEDLE WOULD NOT RETRACT AND STUCK PCT'S FINGER. NURSE MANAGER PUT LANCET IN SPECIMEN CONTAINER AND THE NEEDLE DID EVENTUALLY RETRACT WITH SOME MOVEMENT. IT APPEARS THERE WAS AN ISSUE WITH THE SAFETY MECHANISM. THE PCT CLEANED THE SITE AND DID NOT NEED CARE.
Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions
MAUDE report 20431020 ↗MalfunctionOct 12, 2018Fail-Safe Problem; Protective Measures Problem; Fail-Safe Did Not Operate; Fail-Safe Problem; Protective Measures Problem; Fail-Safe Did Not Operate
HEAD NURSE OF (B)(6) STATED ANOTHER NURSE REPORTED TO HER THAT SHE WAS ALMOST STUCK WITH AN EXPOSED LANCET BECAUSE IT DID NOT RETRACT AFTER TESTING A PATIENT.
Patient problems: Anxiety
MAUDE report 7963167 ↗
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- Unistik Touch AT 1444Owen Mumford Limited · Lancet, Blood4 reports
- Unistik 3 AT 1012Owen Mumford Limited · Lancet, Blood3 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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