device · product 1 of 4
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
- Recall number
- Z-1422-2023
- Initiated
- March 24, 2023
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- Richard Wolf GmbH
- Quantity
- 838 units
App-derived interpretation
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.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
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.
Code information
UDI/DI: 04055207009574; Lot Numbers: 4500377299, 4500377299, 4500371834, 4500374645, 4500369724, 4500367397, 4500363662, 4500363096, 4500359201, 4500356582, 4500353558, 4500350415, 4500347760, 4500345769, 4500341314, 4500341314, 4500338447, 4500336245, 4500334737, 4500334002
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).