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Recall Observatory FDA recall evidence

Device product

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

Z-1423-2023

March 24, 2023

Class II

Product summary

Firm
Richard Wolf GmbH
Event
Event 91953
Status
Ongoing
Classification
Class II
Quantity
342 units
Official record key
device-enforcement:Z-1423-2023

Official wording

Reason: 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: 04055207009635; Lot Numbers: 4500377840, 4500377840, 4500377840, 4500376297, 4500371970, 4500363663, 4500363098, 4500361404, 4500353562, 4500349168, 4500347747, 4500338560, 4500333999

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).

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.