The FDA announced on March 24, 2023, that Richard Wolf GmbH is recalling FLEX. BIOPSY FORCEPS 5FR WL 550MM because the device may fail to open when the endoscope shaft is bent. The recall involves 342 units distributed worldwide.
How to tell if you have it
- Brand: Richard Wolf
- Product: FLEX. BIOPSY FORCEPS 5FR WL 550MM
- Product Number: 829.051
- UDI/DI: 04055207009635
- Lot Numbers: 4500377840, 4500377840, 4500377840, 4500376297, 4500371970, 4500363663, 4500363098, 4500361404, 4500353562, 4500349168, 4500347747, 4500338560, 4500333999
- Distribution: Worldwide
The hazard
According to the FDA, the forceps may be unable to open when the endoscope shaft is bent by about 90 degrees. If the proximal forceps shaft is also bent, the forceps can no longer be opened or restrictions begin with slight bending.
Context
GovInfoNow's records show Richard Wolf GmbH has had six other recalls on record since July 24, 2017. Other recent recalls of similar products include Boston Scientific Radial Jaw 4 Biopsy Forceps (June 30, 2026), Medline Forceps (Nov. 13, 2025), and Boston Scientific Radial Jaw 4 Jumbo Biopsy Forceps (June 30, 2026).