Forceps, Biopsy, Non-Electric
FDA adverse event reports and recall history for forceps, biopsy, non-electric (product code FCL), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 2,705
- Deaths
- 17
- Injuries
- 704
- Malfunctions
- 1,954
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-07-31Open, ClassifiedProcess control
Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3. Radial Jaw 4 SC w/ Needle 240cm Box 20; Outer Box UPN: M00513411; Inner Box UPN: M00513410.
Potential for breach in sterile barrier of device packaging.
- 2026-07-31Open, ClassifiedProcess control
Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial Jaw 4 LC w/Needle 240cm Box 20; Outer Box UPN: M00513331; Inner Box UPN: M00513330. 4. Radial Jaw 4 LC w/Needle 240cm Box 40; Outer Box UPN: M00513332; Inner Box UPN: M00513330. 5. Radial Jaw 4 LC w/Needle 240cm Box 5; Outer Box UPN: M00513333; Inner Box UPN: M00513330.
Potential for breach in sterile barrier of device packaging.
- 2026-07-31Open, ClassifiedProcess control
Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
Potential for breach in sterile barrier of device packaging.
- 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.
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