Unistik Touch AT 1444Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00384701444012), received between Aug 11, 2022 and May 9, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2024Material Separation; Material Separation

  CT FOUND A LANCET THAT WAS DYSFUNCTIONAL AND LEFT THE NEEDLE EXPOSED; CT WAS CHECKING PATIENT'S MORNING BLOOD GLUCOSE. THE BROKEN LANCET WAS DEEMED HAZARDOUS TO BOTH PATIENT AND STAFF. UNCLEAR IF DEVICE WAS ACTUALLY USED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19278924 ↗
• MalfunctionMay 9, 2024Material Separation; Material Separation

  CT FOUND A LANCET THAT WAS DYSFUNCTIONAL AND LEFT THE NEEDLE EXPOSED; CT WAS CHECKING PATIENT'S MORNING BLOOD GLUCOSE. TEH BROKEN LANCET WAS DEEMED HAZARDOUS TO BOTH PATIENT AND STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19278888 ↗
• InjuryAug 11, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  HOSPITAL CALLED SALES REP TO REPORT THAT A CAREGIVER ON 10 WEST WAS ACCIDENTALLY STUCK AFTER STICKING THE PATIENT, WHEN THE NEEDLE DID NOT RETRACT. THEY DID NOT SAVE THE LANCET IN QUESTION, IT WENT INTO THE SHARPS. THE FLOOR MANAGER SAID THEY DID NOT KNOW THE LOT NUMBER OF THE LANCET BECAUSE THEY EMPTY THE LANCETS FROM THE BOX THEY COME IN, INTO A PURPLE HOLDER BIN AND THEN DISCARD THE BOX.

  Patient problems: Exposure to Body Fluids

  MAUDE report 15213756 ↗
• InjuryAug 11, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  HOSPITAL IN US CALLED US SALES REP TO REPORT THAT A CAREGIVER ON 10 WEST WAS ACCIDENTALLY STUCK AFTER STICKING THE PATIENT, WHEN THE NEEDLE DID NOT RETRACT. THEY DID NOT SAVE THE LANCET IN QUESTION, IT WENT INTO THE SHARPS. THE FLOOR MANAGER SAID THEY DID NOT KNOW THE LOT NUMBER OF THE LANCET BECAUSE THEY EMPTY THE LANCETS FROM THE BOX THEY COME IN AND PUT INTO A PURPLE HOLDER BIN AND THEN DISCARD THE BOX.

  Patient problems: Exposure to Body Fluids

  MAUDE report 15213713 ↗