DISPOSABLE BIOPSY FORCEPS FB-224URecalls & reported problems
Olympus Medical Systems Corp. · DISPOSABLE BIOPSY FORCEPS · Class 1
All models of DISPOSABLE BIOPSY FORCEPS (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170354205), received between Jul 24, 2018 and Jul 24, 2018 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blood Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY INFORMED OLYMPUS THAT PATIENTS ARE EXPERIENCING EXCESSIVE BLEEDING AFTER UNDERGOING PROCEDURES WITH THE SINGLE USE BIOPSY FORCEPS. IT IS NOT KNOWN HOW THE BLEEDING WAS RESOLVED OR IF THE INTENDED PROCEDURES WERE COMPLETED. ADDITIONALLY, THE USER FACILITY REPORTED THAT ALTHOUGH THERE WAS NO ISSUES NOTED WITH THE DEVICE DURING USE IT CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THIS IS REPORT 1 OF 2.
Patient problems: Blood Loss
MAUDE report 7716639 ↗
Other FORCEPS, BIOPSY, NON-ELECTRIC devices
- Radial Jaw 4 M00513410Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall24 reports
- Radial Jaw 4 M00513330Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall19 reports
- Radial Jaw 4 M00513400Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall16 reports
- NA 8736685Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall15 reports
- NA 828051Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall6 reports
- Radial Jaw 4 M00513320Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall3 reports
- Radial Jaw 4 M00513360Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall2 reports
- NA 8735685Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall1 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 · 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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