Home / Recalls / Richard Wolf GmbH / Z-1425-2023

Z-1425-2023 Class II Ongoing

Recalled by Richard Wolf GmbH — Knittlingen, N/A

FDA device recall Z-1425-2023 was initiated by Richard Wolf GmbH on Mar 24, 2023 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 280 units.

Recall Details

Product Type: Devices
Report Date: May 3, 2023
Initiation Date: Mar 24, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 280 units

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.

Distribution Pattern

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).

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1425-2023
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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