PlainRecalls
FDA Devices Moderate Class II Ongoing

FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051

Reported: May 3, 2023 Initiated: March 24, 2023 #Z-1422-2023

Product Description

FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051

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.

Details

Recalling Firm
Richard Wolf GmbH
Units Affected
838 units
Distribution
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).
Location
Knittlingen, N/A

Frequently Asked Questions

What product was recalled?
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051. Recalled by Richard Wolf GmbH. Units affected: 838 units.
Why was this product 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 agency issued this recall?
This recall was issued by the FDA Devices on May 3, 2023. Severity: Moderate. Recall number: Z-1422-2023.