The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1423-2023·Announced 2023-05-03

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units
342

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.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Richard Wolf GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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