Z-1559-2015Class II

Caviwave Pro Ultrasonic Cleaning System

Name: Z-1559-2015 Caviwave Pro Ultrasonic Cleaning System
Creator: Steris Corporation
Published: 2015-02-19
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2015-02-19 / Terminated / root cause: software

FDA source

Steris Corporation began a recall of Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry laparoscopic and general surgical... on 2015-02-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1559-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-19
Posted: 2015-04-30
Terminated: 2015-10-21
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.
Product code: MDZ Cleaners, Medical Devices
Reason for recall: 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 tag: software
FDA 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 in commerce: 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.
Product codes and lots: All units distributed between 12/20/2010 and 02/18/2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1559-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1559-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-30

Product code MDZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)