Richard Wolf Medical Instruments Corp.
United Statesfrom the FDA registration address FDA establishment FEI 1418479
- Devices
- 156
- Registrations
- FDA
- FDA recalls
- 12
What Richard Wolf Medical Instruments Corp. makes
The company manufactures surgical and endoscopic instruments, including spray needles, trocars with automatic protective mechanisms, and resection tools such as pumps, resectoscopes, and endoscopes with chip aspiration capabilities. Additional products include flexible video cystoscopes and choledochoscopes, endo-surgical devices, instruments for vein harvesting and tissue dissection, knot slides, and specialized light sources like xenon lamps. Accessories for endoscopes, hysteroscopes, and operating systems are also part of the portfolio, along with telescopes and fiber-optic laparoscopes.
The portfolio includes devices classified under FDA regulations as Class I, Class II, and Class III, with submissions documented through 510(k) and PMA pathways. These products are intended for use in minimally invasive procedures, urology, gynecology, and general surgery. The company is based in the United States.
Catalogue
Search and filter all 156 devicesShowing 1-50 of 156
Company details
- FDA FEI number
- 1418479
- Address
- 353 CORPORATE WOODS PKWY., VERNON HILLS, IL, 60061
FDA recalls
FDA recall records list 12 recalls initiated by RICHARD WOLF MEDICAL INSTRUMENTS CORP., the earliest on 2004-02-02 and the most recent on 2019-05-23. By recorded status: 12 terminated. The reasons filed fall into these groups: sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 23 May 2019 Z-1957-2019 Class II Terminated E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.
2016
- 19 May 2016 Z-2608-2016 Class II Terminated The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients.
Full distribution text
- 29 Feb 2016 Z-1188-2016 Class II Terminated Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts and support arms may be missing riveting.
- 19 May 2016 Z-2608-2016 Class II Terminated The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients.
2015
- 25 Nov 2015 Z-0789-2016 Class II Terminated 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.
- 25 Nov 2015 Z-0790-2016 Class II Terminated 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.
- 25 Nov 2015 Z-0791-2016 Class II Terminated 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.
2014
- 10 Dec 2014 Z-1240-2015 Class II Terminated 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.
- 9 Jul 2014 Z-0037-2015 Class II Terminated 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.
Full distribution text
2013
- 18 Sep 2013 Z-0145-2014 Class II Terminated Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.
2009
- 16 Oct 2009 Z-0272-2010 Unclassified (pre-2012) Terminated The sterile pouch seal may fail to remain intact during handling rendering the Hulka clip non-sterile.
Show all 12 recalls
2006
- 7 Jul 2006 Z-1430-06 Unclassified (pre-2012) Terminated The irrigation tubing in the tube set was assembled incorrectly with the connectors reversed.
Full distribution text
- 7 Jul 2006 Z-1430-06 Unclassified (pre-2012) Terminated The irrigation tubing in the tube set was assembled incorrectly with the connectors reversed.
2004
- 2 Feb 2004 Z-0537-04 Unclassified (pre-2012) Terminated If the drain tube is assembled incorrectly, the suction pump will not operate as intended.
Frequently asked questions
How many devices does RICHARD WOLF MEDICAL INSTRUMENTS CORP. have in the registry?
The registry currently lists 156 devices for RICHARD WOLF MEDICAL INSTRUMENTS CORP.. Devices recorded under merged duplicate company entries are counted once.
Which registries list RICHARD WOLF MEDICAL INSTRUMENTS CORP.'s devices?
Among its 50 most recently registered devices, RICHARD WOLF MEDICAL INSTRUMENTS CORP. has devices listed in FDA 510(k) (49 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do RICHARD WOLF MEDICAL INSTRUMENTS CORP.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for RICHARD WOLF MEDICAL INSTRUMENTS CORP.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for RICHARD WOLF MEDICAL INSTRUMENTS CORP.?
FDA recall records list 12 recalls initiated by RICHARD WOLF MEDICAL INSTRUMENTS CORP., the most recent initiated on 2019-05-23. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from RICHARD WOLF MEDICAL INSTRUMENTS CORP. in the registry?
The most recently registered devices listed for RICHARD WOLF MEDICAL INSTRUMENTS CORP. include SUCTION AND IRRIGATION TUBES, Hulka Clips 4986.90, NEEDLE, SPRAY and TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM.