Accu-Chek SoftclixRecalls & reported problems across all models
Roche Diabetes Care GmbH · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 148
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 4 models of Accu-Chek Softclix by Roche Diabetes Care GmbH in the FDA's device registry (GUDID). Together they are named in 148 adverse event reports in the FDA's MAUDE database, received between Jan 24, 2019 and Jul 29, 2026 — classified as 1 injury, 147 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (137 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Accu-Chek Softclix problems
Device problems
- Retraction Problem137
- Material Fragmentation4
- Material Separation4
- Adverse Event Without Identified Device or Use Problem1
- Component Missing1
- Delivered as Unsterile Product1
- High Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions141
- No Known Impact Or Consequence To Patient2
- Device Embedded In Tissue or Plaque1
- Impaired Healing1
- Needle Stick/Puncture1
- No Consequences Or Impact To Patient1
- Skin Infection1
Accu-Chek Softclix models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Accu-Chek Softclix 05181186001Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature133 reports
- Accu-Chek Softclix 11893238160Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature8 reports
- Accu-Chek Softclix 05509661001Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature5 reports
- Accu-Chek Softclix 03144844001Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature2 reports
Recent Accu-Chek Softclix adverse event reports
The 15 most recent reports across all models, 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 30, 2026Material Separation
IT WAS REPORTED THAT THE STERILITY CAP WAS MISSING FROM ONE LANCET IN THE BOX RESULTING IN AN ACCIDENTAL FINGER STICK. NO MEDICAL ATTENTION WAS REQUIRED FOR THE FINGER STICK.
Patient problems: Needle Stick/Puncture
MAUDE report 24727411 ↗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 ↗
Other Roche Diabetes Care GmbH products
All Roche Diabetes Care GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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