SteriGear A4092-81Recalls & reported problems
Sterigear, LLC · The Fig Leaf 10270 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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 16, 2026.
Recalls naming this device
- Jan 11, 2011Terminated
SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return valve closed.
Z-1848-2014 · Root cause: Device Design · Recall details · FDA record ↗
Other Urinary drainage collection kit, for indwelling catheter devices
- Dover FPP12ULCardinal Health, Inc. · Urinary drainage collection kit, for indwelling catheter1 report
- Dover FPP18ULCardinal Health, Inc. · Urinary drainage collection kit, for indwelling catheter1 report
- Dover P4P16CSDK2Cardinal Health 200, LLC · Urinary drainage collection kit, for indwelling catheter1 report
- Dover 6165LLCardinal Health, Inc. · Urinary drainage collection kit, for indwelling catheter1 report
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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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