Richard Wolf Medical Instruments Corp.
353 CORPORATE WOODS PKWY., VERNON HILLS, IL, US
Registered product codes
30 product codes
Recent MDR events
300 on file
- E-LINEMay 29, 2026Injury1418479-2026-00003
- WOLF D.O.C. SEMI-RIGID URETEROSCOPEApr 22, 2026InjuryMW5187188
- NAFeb 25, 2026Malfunction24442324
- SHARK/S-LINESep 26, 2025Malfunction23154259
- VIPERJul 15, 2025Malfunction1418479-2025-00006
- WOLFE INNER SHEATH RESECTOSCOPEAug 14, 2024MalfunctionMW5158444
- SHEATH/SCOPEAug 14, 2024MalfunctionMW5158447
- RICHARD WOLF PIRANHA ENDOSCOPIC MORCELLATORMar 27, 2024MalfunctionMW5153306
- BOVIE CORDMar 27, 2024InjuryMW5153308
- VIPERDec 5, 2023Injury1418479-2023-00022
Recalls
12 on file
- TerminatedJun 13, 2019
E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.
View FDA record ↗ - TerminatedFeb 9, 2016
Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.
View FDA record ↗ - TerminatedFeb 9, 2016
Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.
View FDA record ↗ - TerminatedFeb 9, 2016
Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.
View FDA record ↗ - TerminatedMar 3, 2015
The transformers installed on carts used for Richard Wolf medical video systems may overheat causing smoke and black plastic material to leak from the cart chassis.
View FDA record ↗ - TerminatedNov 6, 2014
Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The devices are being recalled as a part of an investigation into a biocompatibility test discrepancy where the recalled lot (lot 51000232) passed final release testing, but the subsequent lot failed biocompatibility testing on a component that was also used to manufacture lot 51000232.
View FDA record ↗ - TerminatedNov 4, 2013
Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.
View FDA record ↗ - TerminatedNov 17, 2009
The sterile pouch seal may fail to remain intact during handling rendering the Hulka clip non-sterile.
View FDA record ↗ - TerminatedAug 24, 2006
The irrigation tubing in the tube set was assembled incorrectly with the connectors reversed.
View FDA record ↗ - TerminatedFeb 11, 2004
If the drain tube is assembled incorrectly, the suction pump will not operate as intended.
View FDA record ↗
Compliance history
Matched by FEI 1418479.
FDA inspections
2 on file
- No Action Indicated (NAI)Jan 13, 2025
Compliance: Devices
- No Action Indicated (NAI)Jan 13, 2025
Postmarket Assurance: Devices
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.