Recall Register

Device recall: Reliance Synergy Washer/Disinfector

Class II FDA enforcement event 90222. Recall start date: . Status in the FDA record: Terminated. Termination date: .

Reason for recall, in the words of FDA

The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Steris Corporation started this device recall on 22 Apr 2022. The firm address in the FDA record is in Mentor, OH. FDA put the recall in Class II. FDA event 90222 has 1 product record. The first FDA enforcement report date is 15 Jun 2022. The record gives the status Terminated, with the termination date 4 Nov 2024.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

Worldwide distribution - US Nationwide.

Recalling firm

Steris Corporation, Mentor, OH.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 90222: product records
Recall numberProductQuantityClassStatusReport date
Z-1256-2022Reliance Synergy Washer/Disinfector3,863 total units (2,776 US; 1,087 OUS)Class IITerminated15 Jun 2022

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2022
839
Share of these events in Class II
88%
Product records in this event
1Median of the firm: 1
Events of the firm on the register
58

Other events of the firm

Official channels

Cite this page

Recall Register. FDA enforcement event 90222. https://recallregister.com/fda/ii/90222/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA device enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: Worldwide distribution - US Nationwide.
What quantity of product is in FDA event 90222?
The FDA record gives this quantity: 3,863 total units (2,776 US; 1,087 OUS)
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many device recalls of 2022 have the same class?
88% of the 839 device events that started in 2022 are in Class II.