Class 2 Device Recall Richard Wolf

• Date Initiated by Firm: March 24, 2023
• Date Posted: April 24, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1425-2023
• Recall Event ID: 91953
• Product Classification: Forceps, biopsy, non-electric - Product Code FCL
• Product: FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685
• Code Information: UDI/DI: 04055207020289; Lot Numbers: 4500377853, 4500371811, 4500377297, 4500371813, 4500367418, 4500367417, 4500363668, 4500363104, 4500359203, 4500356576, 4500353566, 4500352416, 4500350353, 4500347761, 4500347761, 4500346491, 4500344550, 4500341309, 4500338558, 4500334010
• FEI Number: 3002808001
• Recalling Firm/ Manufacturer: Richard Wolf GmbH; Pforzheimer Str. 32; Knittlingen Germany
• For Additional Information Contact: Mr. Kevin Dwyer; 847-913-1113 Ext. 213
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm issued an Urgent Medical Device Correction notice on 03/24/2023 to its consignees by USPS certified mail. The notice explained the issue and explained the proper use of the device to avoid exposing patients to improper handling. Richard Wolf is already optimizing the forceps design. Further batches of these forceps can be used with the expected maximum flexibility. The procedure described in the notice does not expose patients to risks from jaw sections that do not open. The firm issued a follow up letter titled, Urgent Medical Device Removal beginning on 08/02/2023, via USPS certified mail. The notice advised customers that the device has been redesigned. Customers were instructed to review inventory, ensure all users are informed of the recall, notify customers if further distributed, return the customer response form, arrange for the shipment of revised forceps and return affected devices. The firm issued an updated letter to customers who have not yet responded to the original notification on about 09/12/2023. The updated letter included an image of where to locate the lot/batch number on the forceps, and the table of lot/batch numbers was also reorganized for better readability.
• Quantity in Commerce: 280 units
• Distribution: Worldwide distribution - US Nationwide and the countries of United Arab Emirates (AE), Argentina (AR), Austria (AT), Belgium (BE), BO, Brazil (BR), Canada (CA), Chile (CL), Czech Republic (CZ), Germany (DE), Denmark (DK), Ecuador (EC), Spain (ES), Finland (FI), France (FR), Greece (GR), Hong Kong (HK), Croatia (HR), Ireland (IE), India (IN), Italy (IT), Jordan (JO), Japan (JP), South Korea (KR), Kuwait (KW), Kazakhstan (KZ), LB, Lithuania (LT), Marzocco (MA), Mexico (MX), Netherlands (NL), Norway (NO), New Zealand (NZ), Oman (OM), Pakistan (PK), Poland (PL), Palestine (PS), Portugal (PT), Qatar (QA), Romania (RO), Serbia (RS), Russian Federation (RU), Saudi Arabia (SA), Slovenia (SI), Slovakia (SK), Thailand (TH), Turkey (TR).
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.