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Aesculap Inc FDA Recalls

18 recalls on file across devices, 0 of them Class I and 18 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software VersClass IIJan 15, 2026There is the potential for the length of the trocar shaft to	There is the potential for the length of the trocar shaft to be too long.	Class IIDevices	Jan 15, 2026
Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software VerClass IISep 24, 2025It was determined there is the potential of silicone fragmen	It was determined there is the potential of silicone fragments detaching from the yellow sealing component.	Class IIDevices	Sep 24, 2025
Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/AClass IISep 24, 2025It was determined there is the potential of silicone fragmen	It was determined there is the potential of silicone fragments detaching from the yellow sealing component.	Class IIDevices	Sep 24, 2025
Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/Class IISep 24, 2025It was determined there is the potential of silicone fragmen	It was determined there is the potential of silicone fragments detaching from the yellow sealing component.	Class IIDevices	Sep 24, 2025
Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: NClass IISep 24, 2025It was determined there is the potential of silicone fragmen	It was determined there is the potential of silicone fragments detaching from the yellow sealing component.	Class IIDevices	Sep 24, 2025
Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM; (2) REF BH304R, Class IIJan 31, 2025The forceps have been used in ways not covered by the design	The forceps have been used in ways not covered by the design resulting in breakage of the clamps.	Class IIDevices	Jan 31, 2025
Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJClass IIJan 31, 2025The forceps have been used in ways not covered by the design	The forceps have been used in ways not covered by the design resulting in breakage of the clamps.	Class IIDevices	Jan 31, 2025
Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2) REF FB459R, GloverClass IIJan 31, 2025The forceps have been used in ways not covered by the design	The forceps have been used in ways not covered by the design resulting in breakage of the clamps.	Class IIDevices	Jan 31, 2025
Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952RClass IIJan 31, 2025The forceps have been used in ways not covered by the design	The forceps have been used in ways not covered by the design resulting in breakage of the clamps.	Class IIDevices	Jan 31, 2025
Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) REF BH104R, HartmannClass IIJan 31, 2025The forceps have been used in ways not covered by the design	The forceps have been used in ways not covered by the design resulting in breakage of the clamps.	Class IIDevices	Jan 31, 2025
Aeos Robotic Digital Microscope, Product Code: PV010Class IIMay 13, 2024Possibility of the robotic arm to drop more than 10cm from i	Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency	Class IIDevices	May 13, 2024
DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.Class IIJan 9, 2024The sterile blister packaging may be damaged, and sterility	The sterile blister packaging may be damaged, and sterility may be compromised.	Class IIDevices	Jan 9, 2024
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.Class IIJan 9, 2024The sterile blister packaging may be damaged, and sterility	The sterile blister packaging may be damaged, and sterility may be compromised.	Class IIDevices	Jan 9, 2024
DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.Class IIJan 9, 2024The sterile blister packaging may be damaged, and sterility	The sterile blister packaging may be damaged, and sterility may be compromised.	Class IIDevices	Jan 9, 2024
DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.Class IIJan 9, 2024The sterile blister packaging may be damaged, and sterility	The sterile blister packaging may be damaged, and sterility may be compromised.	Class IIDevices	Jan 9, 2024
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.Class IIJan 9, 2024The sterile blister packaging may be damaged, and sterility	The sterile blister packaging may be damaged, and sterility may be compromised.	Class IIDevices	Jan 9, 2024
MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";Class IIDec 29, 2023Needle Holder MB215R was inadvertently distributed as MB362R	Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R duri	Class IIDevices	Dec 29, 2023
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"Class IIDec 29, 2023Needle Holder MB215R was inadvertently distributed as MB362R	Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R duri	Class IIDevices	Dec 29, 2023

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