CLASS II ONGOING Device recall · Reported 3 May 2023 · FDA Enforcement Report
Flex. Biopsy Forceps WL, Product Number recalled by Richard Wolf
Richard Wolf is recalling Flex. Biopsy Forceps WL, Product Number 829.051, 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
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-1423-2023
- 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. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
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).
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/DI: 04055207009635; Lot Numbers: 4500377840, 4500377840, 4500377840, 4500376297, 4500371970, 4500363663, 4500363098, 4500361404, 4500353562, 4500349168, 4500347747, 4500338560, 4500333999
Where was it sold?
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).
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Flex. Grasp. Forceps WL, Product Number recalled by Richard Wolf | Richard Wolf | Other | Nationwide | |
| CLASS II | Flex. Grasp. Forceps 6. WL, Product Number recalled by Richard Wolf | Richard Wolf | Other | Nationwide | |
| 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 |
|---|---|---|---|---|---|
| Device | CLASS II | PiezoWave 2 Control Unit, Product Number 100506US recalled | Richard Wolf | Device Malfunction | GA |
| Device | CLASS II | Flex. Grasp. Forceps WL, Product Number recalled by Richard Wolf | Richard Wolf | Other | Nationwide |
| Device | CLASS II | Flex. Grasp. Forceps 6. WL, Product Number recalled by Richard Wolf | Richard Wolf | Other | Nationwide |
| Device | CLASS II | Flex. Grasp. Forceps WL, Product Number recalled by Richard Wolf | Richard Wolf | Other | Nationwide |
| Device | CLASS II | Cutting Electrode Bipo recalled by Richard Wolf | Richard Wolf | Other | Nationwide |
Other Surgical Instruments recalls
All 3,891| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |