Surgical

Reports per year

Source: FDA adverse event reports by year received, 2025–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Top device categories

• Modular Electromechanical Surgical SystemSCV1,302
• Staple, ImplantableGDW67
• Pneumoperitoneum NeedleFHO2
• Clip, ImplantableFZP1
• Electrosurgical, Cutting & Coagulation & AccessoriesGEI1
• Left Atrial Appendage Clip, ImplantablePZX1

Recent recalls

• 2026-10-07Open, ClassifiedNonconforming Material/Component

  Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249

  A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may overheat and pose a fire safety risk.

• 2026-10-06Open, ClassifiedLabeling mix-ups

  Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M

  Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

• 2026-10-06Open, ClassifiedLabeling mix-ups

  Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M

  Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

• 2026-08-31Open, ClassifiedDevice Design

  HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET PRO II, REF: 10301016 (EU)

  Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment.

• 2026-07-10Open, ClassifiedProcess control

  da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15

  Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.

• 2026-07-09Open, ClassifiedProcess control

  TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components

  Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.

• 2026-07-09Open, ClassifiedSoftware design (manufacturing process)

  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.

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

• 2026-07-02Open, ClassifiedUnder Investigation by firm

  Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A

  Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

• 2026-07-02Open, ClassifiedUnder Investigation by firm

  Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A

  Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

• 2026-06-22Open, ClassifiedProcess control

  Da Vinci ASSY, PSS, SP1098, Part Number: 380601

  Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.