Z-1423-2023Class II

FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051

Name: Z-1423-2023 FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
Creator: Richard Wolf GmbH
Published: 2023-03-24
License: https://open.fda.gov/license/

Richard Wolf GmbH / initiated 2023-03-24 / Open, Classified

FDA source

Richard Wolf GmbH began a recall of FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051 on 2023-03-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1423-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-24
Posted: 2023-04-24
Recalling firm: Richard Wolf GmbH
Product: FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
Product code: FCL Forceps, Biopsy, Non-Electric
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 root 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: 342 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).
Product codes and lots: UDI/DI: 04055207009635; Lot Numbers: 4500377840, 4500377840, 4500377840, 4500376297, 4500371970, 4500363663, 4500363098, 4500361404, 4500353562, 4500349168, 4500347747, 4500338560, 4500333999

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1423-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1422-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-24
Z-1423-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-24
Z-1424-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-24
Z-1425-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-24

Product code FCL

K971315Class IAuxiliary Instruments for UrsRichard Wolf Medical Instruments Corp. / cleared 1997-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)