Richard Wolf GmbH

FDA Regulatory Profile

Summary

Total Recalls
10
510(k) Clearances
1
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1753-2025Class IIPiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy dApril 9, 2025
Z-1422-2023Class IIFLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051March 24, 2023
Z-1423-2023Class IIFLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051March 24, 2023
Z-1425-2023Class IIFLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685March 24, 2023
Z-1424-2023Class IIFLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685March 24, 2023
Z-2246-2021Class IICUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323June 25, 2021
Z-2706-2020Class IITube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and theJune 5, 2020
Z-0804-2019Class IIRichard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to October 17, 2018
Z-1868-2018Class IIRICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.March 11, 2018
Z-2897-2018Class IIArtholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other nJuly 24, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K962799MINIATURE LAPAROSCOPE SET (MINI LAP)October 11, 1996