Aesculap, Inc.
3773 CORPORATE PKWY., CENTER VALLEY, PA, US
Registered product codes
318 product codes
Recent MDR events
926 on file
- AESCULAPJul 15, 2026Malfunction2916714-2026-00022
- N/AJun 23, 2026Injury2916714-2026-00021
- AESCULAP PRESTIGE LINE ATRAUMATIC LAPAROSCOPIC GRASPING FORCEPSJun 17, 2026MalfunctionMW5189621
- AESCULAPJun 12, 2026Malfunction2916714-2026-00019
- AESCULAPJun 3, 2026Malfunction2916714-2026-00018
- AESCULAPMay 6, 2026Malfunction2916714-2026-00016
- N/AApr 30, 2026Injury2916714-2026-00017
- N/AApr 7, 2026Malfunction2916714-2026-00012
- AESCULAPApr 7, 2026Injury2916714-2026-00013
- AESCULAPMar 25, 2026Malfunction24686291
Recalls
44 on file
- Open, ClassifiedMar 2, 2026
There is the potential for the length of the trocar shaft to be too long.
View FDA record ↗ - Open, ClassifiedOct 24, 2025
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
View FDA record ↗ - Open, ClassifiedOct 24, 2025
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
View FDA record ↗ - Open, ClassifiedOct 24, 2025
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
View FDA record ↗ - Open, ClassifiedOct 24, 2025
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
View FDA record ↗ - Open, ClassifiedMar 11, 2025
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
View FDA record ↗ - Open, ClassifiedMar 11, 2025
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
View FDA record ↗ - Open, ClassifiedMar 11, 2025
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
View FDA record ↗ - Open, ClassifiedMar 11, 2025
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
View FDA record ↗ - Open, ClassifiedMar 11, 2025
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
View FDA record ↗
Compliance history
Matched by FEI 2916714.
FDA inspections
1 on file
- No Action Indicated (NAI)Jul 11, 2025
Compliance: Devices
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.