Recall Z-1425-2023— Richard Wolf GmbH

Name: FDA recall Z-1425-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-24

Class II · Ongoing

Class II FDA medical device recall by Richard Wolf GmbH, initiated 2023-03-24. FDA's recall record names no specific 510(k) clearance for this event. Product: FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685. Reason: 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..

Recalling firm: Richard Wolf GmbH
Classification: Class II
Status: Ongoing
Initiated: 2023-03-24
Firm location: Knittlingen, N/A, Germany

Product description

FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.