Accu-Chek Softclix 05181186001Recalls & reported problems
Roche Diabetes Care GmbH · Accu-Chek Softclix Black Bulk 100 · Class 2
All models of Accu-Chek Softclix (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Accu-Chek Softclix is a single-use blood lancet. Most of the 135 reports describe the lancet failing to retract back into the device, with the tip protruding past the end cap. There are no deaths or injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 133
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 04015630082209), received between Feb 7, 2023 and Jul 29, 2026 — classified as 133 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (132 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 Problem132
- High Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions133
Recent adverse event reports
The 25 most recent of 133 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50065348 ↗MalfunctionJul 29, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50065316 ↗MalfunctionJul 27, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50037206 ↗MalfunctionJun 9, 2026Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25445496 ↗MalfunctionMay 14, 2026Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25171243 ↗MalfunctionMay 8, 2026Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25125092 ↗MalfunctionMay 4, 2026Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25067065 ↗MalfunctionMar 26, 2026Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24697357 ↗MalfunctionFeb 23, 2026Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24414717 ↗MalfunctionFeb 16, 2026Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343865 ↗MalfunctionJan 27, 2026Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24192821 ↗MalfunctionJan 22, 2026Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24146002 ↗MalfunctionDec 22, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET DID NOT RETRACT FROM THE LANCET DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23873477 ↗MalfunctionDec 22, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET DID NOT RETRACT FROM THE LANCET DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23873468 ↗MalfunctionDec 18, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23838889 ↗MalfunctionDec 17, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828718 ↗MalfunctionDec 15, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23802875 ↗MalfunctionDec 10, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23765802 ↗MalfunctionDec 10, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23765752 ↗MalfunctionDec 1, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23679972 ↗MalfunctionNov 19, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23595588 ↗MalfunctionNov 18, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23582755 ↗MalfunctionNov 5, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23473718 ↗MalfunctionNov 3, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23449846 ↗MalfunctionOct 29, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23412533 ↗
Other Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature devices
- OneTouch Delica Plus Lancet 02400801Asahi Polyslider Company,Limited · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature1 recall0 reports
- OneTouch Delica Plus Lancet 02401101Asahi Polyslider Company,Limited · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature1 recall0 reports
- FreeStyle 70469Abbott Diabetes Care Inc · Single use only blood lancet without an integral sharps injury prevention feature1 recall0 reports
- Accu-Chek Softclix 11893238160Roche Diabetes Care GmbH · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature8 reports
- Accu-Chek Softclix 05509661001Roche Diabetes Care GmbH · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature5 reports
- TRUEplus TRUEplus Sterile LancetsTrividia Health, Inc. · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature4 reports
- Accu-Chek Softclix 03144844001Roche Diabetes Care GmbH · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature2 reports
- TRUEplus Good Neighbor Pharmacy TRUEplus Sterile LancetsTrividia Health, Inc. · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature2 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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