Forceps, Biopsy, Non-Electric
FDA adverse event reports and recall history for forceps, biopsy, non-electric (product code FCL), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,695
- Deaths
- 17
- Injuries
- 702
- Malfunctions
- 1,947
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-04-24Open, ClassifiedUnder Investigation by firm
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.
- 2023-04-24Open, ClassifiedUnder Investigation by firm
FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.
- 2023-04-24Open, ClassifiedUnder Investigation by firm
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685
Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.
- 2023-04-24Open, ClassifiedUnder Investigation by firm
FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685
Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.
- 2016-08-22TerminatedUnknown/Undetermined by firm
Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
- 2010-06-04TerminatedProcess control
Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Inner Pouch 240cm, Box 20 UPN/Catalog Number: M00513331
Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result.
- 2010-06-04TerminatedProcess control
Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Box 80, 240cm UPN/Catalog Number: M00513334
Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result.
- 2010-06-04TerminatedProcess control
Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps UPN/Catalog Number: MOO513330 The Radial Jaw 4 Large Capacity Inner Pouch, 240cm UPN M00513330 is a single unit which is packaged into a Box of 20 units (UPN M00513331), and a Box of 80 units (UPN M00513334). Single packaged units of M00513330 are not sold individually.
Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result.
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