Aesculap Inc

10 FDA enforcement actions

10 Total Recalls

0 Class I

10 Class II

0 Class III

Firm Details

Product Types: device
States: PA

All Recalls

Class II: Risk 09/24/2025 device

It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Class II: Risk 09/24/2025 device

It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Class II: Risk 09/24/2025 device

It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Class II: Risk 09/24/2025 device

It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Class II: Risk 01/31/2025 device

The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Class II: Risk 01/31/2025 device

The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Class II: Risk 01/31/2025 device

The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Class II: Risk 01/31/2025 device

The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Class II: Risk 01/31/2025 device

The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Class II: Risk 05/13/2024 device

Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.