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Richard Wolf GmbH Recall 91953

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

Richard Wolf GmbH Recall 91953 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1423-2023
Event ID91953
Event DescriptionFLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
Product TypeDevices
DistributionWorldwide 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).
Quantity390 units
Recall ReasonPotentially 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.
Device Classification20230503
Device Code InfoUDI/DI 04055207009635, Lot Numbers: 4500377840, 4500377840, 4500377840, 4500376297, 4500371970, 4500363663, 4500363098, 4500361404, 4500353562, 4500349168, 4500347747, 4500338560, 4500333999
Center Classification Date20230424
Recall Initiation Date20230324
Recalling FirmRichard Wolf GmbH
Initial Notification Letter
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