FDA Medical Device Recalls (openFDA)
Steris Corporation: Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry laparoscopic and general surgical instruments prior to final disinfection and sterilization as required.
- Recall number
- Z-1559-2015
- Recalling firm
- Steris Corporation
- Product
- Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry laparoscopic and general surgical instruments prior to final disinfection and sterilization as required.
- Status
- Terminated
- Initiated
- 2015-02-19
- Posted
- 2015-04-30
- Terminated
- 2015-10-21
- Reason
- Should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electrical power during a processing cycle, the circulation pump may stop functioning. In addition, it is possible that the ultrasonic generator may stop working. The machine does not provide an alert notifying the user of this device malfunction.
- Root cause
- Software design
- Action
- STERIS sent an Urgent Field Correction Notice letter dated March 9, 2015 customers. The letter identified the description of the product, description of the problem and actions to be taken. For questions contact STERIS Customer Service at 1-800-548-4873 or local sales representative.
- Quantity
- 491 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH,NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV and the countries of: Australia, Brazil, Canada, France, Mexico, Saudi Arabia, Spain, Taiwan & United Arab Emirates.
- Lot, serial or model codes
- All units distributed between 12/20/2010 and 02/18/2015
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MDZ
- Firm FEI
- 1527821
- Firm city
- Mentor
- Firm state
- OH
- 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