InnoWave Sonic Irrigator — Class II medical device recall Z-2700-2020
Terminated recall by Steris Corporation, reported 2020-08-05, distributed nationwide. A recent FDA inspection at the firm identified that the foil test performed during installation of the device
| Recall number | Z-2700-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2020-06-26 |
| Classified | 2020-07-24 |
| Reported by FDA | 2020-08-05 |
| Terminated | 2020-12-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, MX |
| Quantity | 1,283 |
| Serial numbers | 00190039508, 0063707, 01167539804, 01167539810, 01177735901, 01177735902, 01177735903, 01177735904, 01177735905, 01177735906, 01177736802, 01177736803, 01177736804, 01177736805, 01177736806, 01177736807, 01177736808, 01188948301, 01188948302, 01188948303, 01188948304, 01188948305, 01188948306, 01188948307, 01188948308 and 475 more |
Product
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.
Reason for recall
A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
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-2700-2020. 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.