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
Check against the official notice below — it lists the full affected range.
Steris Corporation is recalling 1,283 InnoWave Sonic Irrigators across six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) due to an FDA inspection finding that the foil test performed during device installation lacks clear acceptance criteria. The devices have been distributed nationwide in the United States as well as in Canada, Mexico, and the United Arab Emirates.
The recall affects numerous specific serial numbers of the devices. The source document does not specify a remedy or course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
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. Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, Mexico, and United Arab Emirates. Quantity: 1283 Lot/code info: 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 06178460906 06178460907 0817 87702 01 0817 87702 02 06178460908 06178460909 06178460910 06178460911 06178460912 06178460913 06178460914 06178460915 05178203713 08178478301 06178204011 08178478302 08178478303 06178204012 08178478304 08178478305 08178478306 08178478307 08178478308 06178460917 08178478309 08178478310 08178478311 08178478312 08178478314 08178478315 0917 88031 01 0917 88031 02 0917 88031 03 0917 88031 04 0917 88031 05 0817 87702 04 0817 87702 03 07178460918 09178427701 09178427702 09178427703 09178427704 09178427705 06178204005 09178803106 09178803107 09178803108 091
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.