FDAClass II · Medical device · Recall Z-0118-2027 · Recalled October 14, 2026

HexaVue Focus Integration System recall — Steris Corporation

Agency report date: October 14, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: HexaVue Focus Integration System
Company / brand: Steris
Lot / serial / date codes: 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
Distribution: Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand.

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: HexaVue Focus Integration System recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-0118-2027
Brand: All Steris recalls
Classification: Class II
Units affected: 58 systems
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

HexaVue Focus Integration System recall status

Companies & origin

Recalling firm location: Mentor, OH, United States
Firm address: 5960 Heisley Rd, N/A, 44060-1834

Identifying details (verbatim from the notice)

Product codes / lots: 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
Distribution: Worldwide - US Nationwide and the countries of Australia, Canada, New Zealand.
Firm notified the public via: N/A
FDA event ID: 99856
Recall initiated: September 23, 2026
FDA classified: October 7, 2026
FDA report date: October 14, 2026

Other medical device recalls from around the same time

VentStar Resus Neo recall — Draeger, Inc.FDA · October 7, 2026
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED recall — Medline Industries, LPFDA · October 7, 2026
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories recall — Medline Industries, LPFDA · October 7, 2026
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5 recall — Boston Scientific CorporationFDA · September 30, 2026
Halyard IV START KIT NON-STERILE recall — AVID Medical, Inc.FDA · September 30, 2026

Verify with the official sources:

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FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.

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