CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report

HexaVue Focus Integration System, a single recalled by Steris

Steris is recalling HexaVue Focus Integration System, a single, all-in-one system that handles operating room, distributed nationwide in the US. The recall was initiated on 23 Sep 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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 recalled58 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0118-2027
FDA event ID: 99856
Recalling firm: Steris, Mentor, OH
Classification: Class II
Status: Ongoing
Recall initiated: 23 Sep 2026
FDA classified: 7 Oct 2026
Reported: 14 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

23 Sep 2026	Recall initiated by company
7 Oct 2026	Classified by FDA	+14 days
14 Oct 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Steris

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14 Oct 2026Device	CLASS II	Verify Biological Steam Test Pack recalled by Steris	Steris	Sterility	Nationwide
14 Oct 2026Device	CLASS II	Verify Biological/Integrator Challenge Pack recalled by Steris	Steris	Sterility	Nationwide
14 Oct 2026Device	CLASS II	Verify Dual Species Self-Contained Biological Indicator recalled	Steris	Sterility	Nationwide
14 Oct 2026Device	CLASS II	Verify Dual Species Self-Contained Biological Indicator recalled	Steris	Sterility	Nationwide
14 Oct 2026Device	CLASS II	Verify Biological/Integrator Challenge Pack recalled by Steris	Steris	Sterility	Nationwide

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Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Adaptable Beach Chair Beach Chair surgical patient positioner recalled	Quantum OPS	Device Malfunction	Nationwide
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14 Oct 2026Device	CLASS II	Halyard Laparoscopy Comprehensive Pack II recalled	GRI Medical & Electronic Technology	Other	Nationwide
14 Oct 2026Device	CLASS II	Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Gyn Laparoscopy Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide