Device recall: HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical…

Class II FDA enforcement event 99856. Recall start date: 23 Sep 2026. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.

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 23 Sep 2026. The firm address in the FDA record is in Mentor, OH. FDA put the recall in Class II. FDA event 99856 has 1 product record. The first FDA enforcement report date is 14 Oct 2026. The record gives the status Ongoing. 278 of the 677 device events that started in 2026 have more product records. The median device event of 2026 has 1 product record.

FDA enforcement report The 1 product record

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 1 Oct 2026. openFDA export of 27 Oct 2026.

Distribution

In the words of FDA.

Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand.

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 99856: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0118-2027	HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.0.18	58 systems	Class II	Ongoing	14 Oct 2026

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 2026: 677
Share of these events in Class II: 87%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 61

Other events of the firm

Other FDA enforcement events of Steris Corporation
Initiated	Product (first record)	Type	Class	Records
21 Sep 2026	RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115	Device	Class II	3
31 Aug 2026	VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006	Device	Class II	6
15 May 2026	HarmonyAIR A-Series Surgical Lighting System	Device	Class II	1
15 May 2026	HarmonyAIR A-Series Surgical Lighting System	Device	Class II	2
19 Nov 2025	AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is	Device	Class II	2
23 Jun 2025	Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems	Device	Class II	2
23 May 2025	Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H	Device	Class II	1
13 Jun 2024	Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Autom	Device	Class II	4
12 Dec 2023	Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754	Device	Class II	2
16 Nov 2023	V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended	Device	Class II	1

Steris Corporation: all 61 events

Official channels

FDA enforcement report Z-0118-2027The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 99856. https://recallregister.com/fda/ii/99856/. Source: openFDA enforcement reports. Data through 27 Oct 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 27 Oct 2026
Newest FDA report date on the register: 21 Oct 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 - US Nationwide and the countries of Australia, Canada, New Zealand.
What quantity of product is in FDA event 99856?: The FDA record gives this quantity: 58 systems
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2026 have the same class?: 87% of the 677 device events that started in 2026 are in Class II.