FDA approvals and recalls

Surgery: 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

1,780 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

  • Table, Operating-Room, Electrical

    Reason: There is an issue with the main lift mechanism. The main lift may unexpectedly drop from its set position to its lowest position during use. In these cases, the tabletop could not be raised again aft…

    Z-0350-2027

  • Table, Operating-Room, Electrical

    Reason: There is an issue with the main lift mechanism. The main lift may unexpectedly drop from its set position to its lowest position during use. In these cases, the tabletop could not be raised again aft…

    Z-0352-2027

  • Anesthesia Kit

    Reason: Kits contain infusion sets which were recalled for performance issues.

    Z-0212-2027

  • General Surgery Tray

    Reason: Kits contain infusion sets which were recalled for performance issues.

    Z-0216-2027

  • Tray, Surgical

    Reason: Kits contain infusion sets which were recalled for performance issues.

    Z-0217-2027

  • Light, Surgical, Accessories

    Reason: 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 discrepanc…

    Z-0118-2027

  • Permanent Defibrillator Electrodes

    Reason: Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential harm of tissue trauma due to implant difficulty.

    Z-0285-2027

  • Suture, Nonabsorbable, Synthetic, Polypropylene

    Reason: Products lack 510(k) clearance.

    Z-0334-2027

  • Suture, Absorbable, Synthetic, Polyglycolic Acid

    Reason: Products lack 510(k) clearance.

    Z-0335-2027

  • Suture, Nonabsorbable, Silk

    Reason: Products lack 510(k) clearance.

    Z-0336-2027

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

510(k) clearances

268 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.

Benchmarks on surgery

Countries side by side on public measures for this topic.

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Market reports on surgery

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Digital Health

3D Laparoscopy Imaging Systems

Worldwide · 2024–2034

View report Digital Health

3D Printing in Medical Application

Worldwide · 2024–2034

View report Medical Devices

Advanced Bipolar Direct Energy Devices

Worldwide · 2024–2034

View report Medical Devices

Aesthetic Lasers and Energy Devices

Worldwide · 2024–2034

View report Healthcare Services

Ambulatory Surgery Center

Worldwide · 2024–2034

View report Healthcare Services

Ambulatory Surgery Centers

Worldwide · 2024–2034

View report

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Single-Use Surgical Devices: Safety vs Waste

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