Recall Z-1425-2023

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 taken

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.