Caviwave Pro Ultrasonic Cleaning System — Class II medical device recall Z-1559-2015
Terminated recall by Steris Corporation, reported 2015-05-06, distributed nationwide. Should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electrical power dur
| Recall number | Z-1559-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2015-02-19 |
| Classified | 2015-04-30 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-10-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BR, CA, ES, FR, MX, SA, TW |
| Quantity | 491 units |
| Reason classes | device malfunction |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1559-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.