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.
133 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.
Reason: Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
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…
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…
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…
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…
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…
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…
Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process.
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…
Reason: Test manufactured with an expired ingredient which may present as either a false negative or positive.
Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.
48 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.
Company: THINK Surgical, Inc.
Company: Neocis, Inc.
Company: Koh Young Technology, Inc.
Company: Vitestro
Company: THINK Surgical, Inc.
Company: Ecential Robotics
Company: Auris Health, Inc., part of Johnson & Johnson MedTech
Company: Procept Biorobotics
Company: Depuy Ireland UC
Company: Procept Biorobotics
Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.
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