FDA Device recall Z-2700-2020
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic I…
- FDA Device
- Class II
- terminated
- Published 2020-08-05
On 2020-08-05 the FDA classified a Class II recall of InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic I… by Steris, citing A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2700-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-26 |
| Published | 2020-08-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Steris |
| Distribution | US |
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
A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
Identifiers
| code_info | Serial numbers 11167539801 11167539802 11167539803 01167539804 12167539806 11167440102 01177735903 11167539811…Serial numbers 11167539801 11167539802 11167539803 01167539804 12167539806 11167440102 01177735903 11167539811 01177735902 01177735901 01177735906 01177735904 01177735905 12167539808 01167539810 02177975001 12167539809 01177736803 01177736804 01177736805 01177736806 01177736808 02177975002 01177736807 02177956701 02177956702 02177956703 02177956704 02177956705 03177956706 02177956710 03177956707 03177956708 02177956711 03177956709 03177956901 03177956902 02177956907 03177956903 03177956904 03177956905 03177956906 03177957111 04177957105 04177957106 04177957107 04177957108 04177957109 04177957110 05178203702 05178203703 05178203704 05178203705 05178203701 05178203706 05178203707 05178203708 05178203709 05178203710 06178204001 06178204002 06178204003 06178204004 06178204006 06178204007 06178204009 01177736802 06178204010 04177957112 04178203711 06178460901 06178460902 06178460903 06178460904 06178460905 06178460 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2700-2020%22
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