Is this recall still active?

The FDA lists the recall as ongoing. The recall is still in progress.

Checked Oct 26, 2026

Class IIMedical device recallOngoing

HexaVue Focus Integration System recall

Recalled by Steris Corporation of Mentor, OH · FDA report 10/14/2026

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class: Class II; Moderate
Status: Ongoing
Recall started: 09/23/2026
Distribution: Nationwide

Reason for recall

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: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Recalled product

Product: 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
Lot and code info: Lot Code: UDI: 00724995245047; Serial Numbers: RL25293001 RL25301003 RL25301004 RL26007031 RL26013044 RL26013045 RL26028062 RL26040066 RL26054029 RL26062001 RL26063005 RL26063007 RL26063013 RL26063014 RL26063019 RL26063021 RL26063022 RL26063023 RL26069033 RL26069034 RL26072049 RL26072052 RL26072053 RL26072055 RL26072056 RL26072056 RL26077072 RL26077073 RL26077074 RL26083077 RL26084078 RL26084080 RL26084081 RL26085083 RL26085084 RL26085085 RL26085086 RL26085087 RL26085088 RL26085089 RL26089090 RL26089091 RL26089092 RL26089093 RL26089094 RL26089095 RL26089096 RL26089097 RL26098098 RL26104099 RL26105102 RL26133103 RL26133104 RL26138105 RL26139106 RL26140114 RL26187116 RL26243121
Quantity: 58 systems
Recall number: Z-0118-2027
Event ID: 99856
Initiated by: Voluntary: Firm initiated

Where it was distributed

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

Nationwide

Recall timeline

09/23/2026Firm started the recall
10/07/2026FDA classified it as Class II
10/14/2026Published in the FDA enforcement report

More recalls from Steris

Frequently asked questions

Why was HexaVue Focus Integration System recalled?: 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.
What does Class II mean?: Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Where was the recalled product sold?: Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand.
Is this recall still active?: The FDA lists the recall as ongoing. The recall is still in progress.

SEC company page: STERIS plc (STE) · financials and records from other agencies

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 10/14/2026 · Do not rely on openFDA to make decisions regarding medical care

Recall at a glance

Class: Class II
Status: Ongoing
Type: Medical device
Reported: 10/14/2026

FDA enforcement report search

What recall classes mean

Class IMost serious: A reasonable chance that using or being exposed to the product will cause serious health problems or death.
Class IIModerate: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Class IIILow risk: Use of or exposure to the product is not likely to cause adverse health consequences.

Classes are assigned by the FDA based on the health hazard.

If you have a recalled product

Stop using or eating it. Check the lot number, UPC or date code against the recall.
Return it to the store or follow the firm's instructions for a refund, repair or disposal.
For medicines, talk to your pharmacist or doctor before stopping a prescription.
Report problems to the FDA through MedWatch or to the CPSC at SaferProducts.gov.

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About this data

Recalls: Recall information comes from NHTSA, FDA, USDA, CPSC and other agencies. A product, vehicle or lot may be affected even if it is not listed here, and listings may be delayed. Check the official recall notice and contact the manufacturer or dealer to confirm whether your item is included.

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