Data / Medical devices / United States / Richard Wolf Medical Instruments Corp.
Richard Wolf Medical Instruments Corp.: FDA-registered device maker in Vernon Hills, IL, United States, 1 510(k) clearance
Richard Wolf Medical Instruments Corp. is registered with the FDA (registration 1418479) in Vernon Hills, IL, United States. It lists 30 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 19, 2001. 11 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1418479
- Address
- 353 Corporate Woods Pkwy., Vernon Hills, IL, United States, 60061
- Owner or operator
- RICHARD WOLF GMBH (8010049)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- March 31, 1978
- Registered through
- 2027
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 19, 2001 | K012309 | RIWO SYSTEM TRAYS | FEB | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 23, 2019 | 82946 | Class II | Terminated | E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes ar | E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03. | accessdata.fda.gov |
| May 19, 2016 | 74656 | Class II | Terminated | Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes. | 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 s | accessdata.fda.gov |
| February 29, 2016 | 73348 | Class II | Terminated | The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures. | Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts and support arms may be missing riveting. | accessdata.fda.gov |
| November 25, 2015 | 73091 | Class II | Terminated | Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. Gen | 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. | accessdata.fda.gov |
| December 10, 2014 | 70220 | Class II | Terminated | The I-Cart is used to store, transport, and power video equipment used in medical procedures. | 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. | accessdata.fda.gov |
| July 9, 2014 | 68777 | Class II | Terminated | The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a | 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 u | accessdata.fda.gov |
| September 18, 2013 | 66457 | Class II | Terminated | Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE | Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch. | accessdata.fda.gov |
| October 16, 2009 | 53586 | Not yet classified | Terminated | Richard Wolf Hulka Clip; for single patient use only; a sterile tubal occluding device; 2 clips per procedure tray/pouch, 10 pouches per shipping carton; Richard Wolf Medical Instruments Corp., Vernon Hills, IL 60061; it | The sterile pouch seal may fail to remain intact during handling rendering the Hulka clip non-sterile. | accessdata.fda.gov |
| July 7, 2006 | 35845 | Not yet classified | Terminated | Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring tube, an insufflation tube, an irrigation tube, a suction tube, a pump tube, and a connection tube; a sterile, disposable, single u | The irrigation tubing in the tube set was assembled incorrectly with the connectors reversed. | accessdata.fda.gov |
| February 2, 2004 | 28227 | Not yet classified | Terminated | Pump Tube, REF 8170,121; Suction Pump Drain Tube; An accessory to the suction pump designed for use with the Richard Wolf Ultrasound Lithotriptor used to disintegrate kidney stones, urinary bladder stones and ureter ston | If the drain tube is assembled incorrectly, the suction pump will not operate as intended. | accessdata.fda.gov |
| October 9, 2003 | 27489 | Not yet classified | Terminated | Sonotrode Probe, a straight nephroscopy probe with a 3.5 mm diameter and 362 mm working length; an accessory to the Richard Wolf Model 2271 Ultrasound Generator Unit 2271; Richard Wolf Medical Instruments Corp., Vernon H | The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device. | accessdata.fda.gov |
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Updated June 13, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.