FDAClass II · Medical device · Recall Z-2717-2026 · Recalled July 15, 2026

Brand Name recall — CMR SURGICAL LIMITED

Agency report date: July 15, 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: Brand Name
Company / brand: CMR SURGICAL
Lot / serial / date codes: UDI-DI 05060548211226 Model No V-SS-1020 Serial Numbers 66495, 66496 Software Revision Version 62.1 There is no expiry date for this device.
Distribution: US Nationwide distribution in the state of California.

Agency product description and boundaries

Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.

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: Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

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: Brand Name recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2717-2026
Brand: All CMR SURGICAL recalls
Classification: Class II
Units affected: 2
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Brand Name recall status

Companies & origin

Recalling firm location: Cambridge, N/A, United Kingdom
Firm address: 1 Evolution Business Park, Milton Road; Cam, N/A

Identifying details (verbatim from the notice)

Product codes / lots: UDI-DI 05060548211226 Model No V-SS-1020 Serial Numbers 66495, 66496 Software Revision Version 62.1 There is no expiry date for this device.
Distribution: US Nationwide distribution in the state of California.
Firm notified the public via: E-Mail
FDA event ID: 99280
Recall initiated: June 9, 2026
FDA classified: July 9, 2026
FDA report date: July 15, 2026

Other medical device recalls from around the same time

Abiomed REF recall — Oscor Inc.FDA · July 22, 2026
Abiomed REF recall — Oscor Inc.FDA · July 22, 2026
Medtronic Harmony Delivery Catheter System recall — Medtronic Heart Valves DivisionFDA · July 8, 2026
A M S recall — Windstone Medical Packaging, Inc.FDA · July 8, 2026
A M S recall — Windstone Medical Packaging, Inc.FDA · July 8, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
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 6:00 PM UTC. Record retrieved October 13, 2026 at 6:00 PM UTC.

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