FDA Medical Device Recalls (openFDA)
Richard Wolf Medical Instrument Corp: 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 Hills, IL 60061
- Recall number
- Z-0081-04
- Recalling firm
- Richard Wolf Medical Instrument Corp
- Product
- 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 Hills, IL 60061
- Status
- Terminated
- Initiated
- 2003-10-09
- Posted
- 2004-07-20
- Terminated
- 2004-02-10
- Reason
- The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device.
- Root cause
- Other
- Action
- Recalled from the hospitals by sales representative telephone calls on 10/9/03 and follow-up visits to retriev the recalled lot and replace the units with a new lot of sonotrodes.
- Quantity
- 10 probes
- Distribution
- Nebraska, Oregon, Minnesota and Illinois.
- Lot, serial or model codes
- Model 8963.535, lot number M000580
- 510(k) numbers
- ["K011065"]
- PMA numbers
- not on file
- Product code
- FFK--
- Firm FEI
- 1418479
- Firm city
- Vernon Hills
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28