Surgical robots: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.

Each number has its full source under its own list below.

Device recalls

133 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source
  • Drape, Surgical, Exempt

    Reason: Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

    Z-0277-2027
  • General Surgery Tray

    Reason: Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or endin…

    Z-0181-2027
  • General Surgery Tray

    Reason: Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or endin…

    Z-0182-2027
  • Gynecological Laparoscopic Kit

    Reason: Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or endin…

    Z-0183-2027
  • Obstetrical Kit

    Reason: Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or endin…

    Z-0185-2027
  • General Surgery Tray

    Reason: The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can…

    Z-3295-2026
  • Gynecological Laparoscopic Kit

    Reason: The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can…

    Z-3297-2026
  • Cardiovascular Procedure Kit

    Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process.

    Z-0098-2027
  • Laparoscopy Kit

    Reason: Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminate…

    Z-3292-2026
  • Qualitative Cleaning Process Protein Indicator

    Reason: Test manufactured with an expired ingredient which may present as either a false negative or positive.

    Z-3032-2026

Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.

510(k) clearances

48 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.

At the source

Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.

FDA approvals and recalls on related topics

All topics

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