CLASS II ONGOING Device recall · Reported 3 May 2023 · FDA Enforcement Report

Flex. Grasp. Forceps 6. WL, Product Number recalled by Richard Wolf

Richard Wolf is recalling Flex. Grasp. Forceps 6. WL, Product Number 8736.685, distributed nationwide in the US. The recall was initiated on 24 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI: 04055207020289; Lot Numbers: 4500377853, 4500371811, 4500377297, 4500371813, 4500367418, 4500367417, 4500363668, 4500363104, 4500359203, 4500356576, 4500353566, 4500352416, 4500350353, 4500347761, 4500347761, 4500346491, 4500344550, 4500341309, 4500338558, 4500334010

Quantity recalled280 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1425-2023
FDA event ID: 91953
Recalling firm: Richard Wolf, Knittlingen, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 24 Mar 2023
FDA classified: 24 Apr 2023
Reported: 3 May 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

24 Mar 2023	Recall initiated by company
24 Apr 2023	Classified by FDA	+31 days
3 May 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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).

Nationwide Arkansas California Massachusetts

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 91953

This product is part of a recall event; the main page for the event is Flex. Biopsy Forceps WL, Product Number recalled by Richard Wolf.

Reported	Class	Recall	Company	Reason	Where
3 May 2023	CLASS II	Flex. Biopsy Forceps WL, Product Number recalled by Richard Wolf	Richard Wolf	Other	Nationwide
3 May 2023	CLASS II	Flex. Grasp. Forceps WL, Product Number recalled by Richard Wolf	Richard Wolf	Other	Nationwide
3 May 2023	CLASS II	Flex. Grasp. Forceps WL, Product Number recalled by Richard Wolf	Richard Wolf	Other	Nationwide

More recalls from Richard Wolf

All 10

Reported	Class	Recall	Company	Reason	Where
21 May 2025Device	CLASS II	PiezoWave 2 Control Unit, Product Number 100506US recalled	Richard Wolf	Device Malfunction	GA
3 May 2023Device	CLASS II	Flex. Grasp. Forceps WL, Product Number recalled by Richard Wolf	Richard Wolf	Other	Nationwide
3 May 2023Device	CLASS II	Flex. Grasp. Forceps WL, Product Number recalled by Richard Wolf	Richard Wolf	Other	Nationwide
3 May 2023Device	CLASS II	Flex. Biopsy Forceps WL, Product Number recalled by Richard Wolf	Richard Wolf	Other	Nationwide
18 Aug 2021Device	CLASS II	Cutting Electrode Bipo recalled by Richard Wolf	Richard Wolf	Other	Nationwide

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