Unistik 3 AT 1012Recalls & reported problems
Owen Mumford Limited · Unistik 3 Extra - 21G x 2.0mm, 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 00384701012013), received between Apr 26, 2019 and Feb 24, 2025 — 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
- Insufficient Information2
- Anxiety1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2025Retraction Problem; Retraction Problem
HOSPITAL SENT EMAIL OF AN ISSUE THEY HAD EXPERIENCED WITH OUR LANCETS. THE EMAIL STATED SOME OF THE LANCETS, DEVICE DOES NOT RETRACT NEEDLE AFTER USE. THEY REPORTED THE NEEDLE LOOSELY DROPS OUT BUT DOESN'T REMAIN WITH THE ORANGE BASE. NO OTHER DETAILS WERE PROVIDED, NOR A SAMPLE SENT.
Patient problems: Insufficient Information
MAUDE report 21453337 ↗MalfunctionFeb 24, 2025Retraction Problem; Retraction Problem
HOSPITAL SENT EMAIL OF AN ISSUE THEY HAD EXPERIENCED WITH OUR LANCETS. THE EMAIL STATED SOME OF THE LANCETS, DEVICE DOES NOT RETRACT NEEDLE AFTER USE. THEY REPORTED THE NEEDLE LOOSELY DROPS OUT BUT DOESN'T REMAIN WITH THE ORANGE BASE. NO OTHER DETAILS WERE PROVIDED, NOR A SAMPLE SENT.
Patient problems: Insufficient Information
MAUDE report 21453284 ↗MalfunctionApr 26, 2019Fail-Safe Problem; Protective Measures Problem; Fail-Safe Did Not Operate; Fail-Safe Problem; Protective Measures Problem; Fail-Safe Did Not Operate
LABORATORY TECHNICAL SUPERVISOR EMAILED AFTER AN EMPLOYEE REPORTED TO HER THAT SHE NOTICED SOME OF THE LANCETS WERE NOT RETRACTING AFTER USE.
Patient problems: Anxiety
MAUDE report 8557828 ↗
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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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