Biopsy forceps may fail to open when endoscope is bent
Biopsy forceps may become unable to open when the endoscope shaft is bent approximately 90 degrees. Additional bending of the forceps shaft can prevent opening entirely.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall without reported injuries or hospitalizations. The device may fail to open under certain conditions, creating a risk-of-harm scenario, but no actual incidents are documented. This fits the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Richard Wolf GmbH is recalling 342 units of the FLEX. BIOPSY FORCEPS 5FR WL 550MM (Product Number 829.051) due to a functional defect. The device may fail to open properly when the endoscope shaft is bent approximately 90 degrees. If the proximal forceps shaft is also bent, the forceps cannot open or may experience restrictions even with slight additional bending.
This malfunction could prevent healthcare professionals from completing biopsy procedures safely and may affect patient safety if the device becomes stuck or non-functional during use. The affected units were distributed worldwide, including the United States, and specific lot numbers have been identified.
Affected healthcare facilities and medical professionals who have received these devices should review the recall information and take appropriate action based on guidance from Richard Wolf GmbH and their healthcare institution's protocols.
The recalled product
- Product
- FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
- Manufacturer
- Richard Wolf GmbH
- Category
- Medical Device — Biopsy Forceps
- Hazard
- forceps-malfunction
- device-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- UDI/DI: 04055207009635
- Lot Numbers: 4500377840
- 4500377840
- 4500376297
- 4500371970
- 4500363663
- 4500363098
- 4500361404
- 4500353562
- 4500349168
- 4500347747
- 4500338560
- 4500333999
Distribution
Distributed nationwide across the United States.
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