Accu-Chek Safe-T-Pro 03448622001Recalls & reported problems
Roche Diabetes Care GmbH · Accu-Chek Safe-T-Pro Plus 200ct · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00075537257890), received between Aug 23, 2021 and Feb 7, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
WE RECEIVED AN ALLEGATION ABOUT MISSING STERILITY COVER/TIP FROM 25 ACCU-CHEK SAFE-T-PRO PLUS LANCETS. NO ALLEGATION OF INJURIES OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18659421 ↗MalfunctionAug 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER ALLEGED THE NEEDLE CAME OUT OF THE SAFE-T-PRO PLUS LANCET DEVICE. THE CUSTOMER ATTEMPTED TO REMOVE THE STERILITY CAP AND DEPTH DIAL WHEN THE NEEDLE CAME OUT OF THE LANCET DEVICE. THE CUSTOMER DID NOT TWIST THE STERILITY CAP WHEN THE LANCET CAME OUT OF THE DEVICE BUT HAD PULLED IT STRAIGHT OFF. THERE WAS NO ACCIDENTAL FINGERSTICK WITH THE SAFE-T PRO PLUS LANCET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12353418 ↗
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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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