Aesculap, Inc. — Federal Records

FDA Device Recall: Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Mod 2026-03-11

Class II — There is the potential for the length of the trocar shaft to be too long.

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FDA Recall: Aesculap Inc — Class II 20250319

The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | Product: Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps H...

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FDA Device Recall: Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Mo 2025-11-05

Class II — It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

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FDA Device Recall: Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Cat 2025-11-05

Class II — It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

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FDA Device Recall: AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. 2025-10-08

Class II — Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

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FDA Device Recall: Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsi 2025-03-19

Class II — The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

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FDA Device Recall: Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hys 2025-03-19

Class II — The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

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FDA Device Recall: Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery 2025-03-19

Class II — The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

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FDA Device Recall: Aeos Robotic Digital Microscope, Product Code: PV010 2024-06-19

Class II — 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.

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FDA Device Recall: DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic proce 2024-03-13

Class II — The sterile blister packaging may be damaged, and sterility may be compromised.

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FDA Device Recall: DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscop 2024-03-13

Class II — The sterile blister packaging may be damaged, and sterility may be compromised.

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FDA Device Recall: DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscop 2024-03-13

Class II — The sterile blister packaging may be damaged, and sterility may be compromised.

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FDA Device Recall: MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILL 2024-02-07

Class II — Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in...

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FDA Device Recall: MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), " 2024-02-07

Class II — Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in...

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FDA Recall: Aesculap, Inc. — Class II 20160309

Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Endu | Product: Columbus Revision Knee System, EnduRo ...

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FDA Device Recall: Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbu 2016-03-09

Class II — Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it is labeled ...

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FDA Recall: Aesculap, Inc. — Class II 20150812

A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to too much torque. The firm | Product: S4C Occiput Torque Wrench F/Set Screw;...

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FDA Device Recall: Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap 2015-12-30

Class II — The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.

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FDA Device Recall: Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG The 2015-12-30

Class II — The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.

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FDA Device Recall: S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal Sy 2015-08-12

Class II — A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to too much torque. The firm did not include instructions for reass...

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FDA Device Recall: Miethke Shunt System accessories Product Usage: - The Miethke Shunt System 2015-02-04

Class II — Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. Th...

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FDA Recall: Aesculap, Inc. — Class II 20140611

AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter. | Product: Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/...

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FDA Device Recall: Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intend 2014-12-24

Class III — Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labels for the miniNAV (FV660T). There are no patient injuries resulting from this...

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FDA Device Recall: Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable poly 2014-07-16

Class II — Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a labeling issue. Box labels d...

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FDA Device Recall: Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt Sys 2014-06-11

Class II — AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.

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FDA Device Recall: Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment sh 2014-02-26

Class II — The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.

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FDA Recall: Aesculap, Inc. — Class II 20131030

Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the life of the product. This included recommen | Product: UNITRAC Pneumatic Retraction Arm. A...

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FDA Device Recall: Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7 2013-12-25

Class II — The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.

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FDA Device Recall: Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coa 2013-12-18

Class II — Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.

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FDA Device Recall: Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US) 2013-11-27

Class II — The trial insertion instrument may disassemble during use due to a potentially weak weld on then trial inserter shaft block area located near the thumb wheel.

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FDA Device Recall: UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instrum 2013-10-30

Class II — Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the life of the product. This included recommending the use of Sterile Cover JG901 and...

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FDA Device Recall: ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vert 2013-07-31

Class II — Aesculap Implant Systems, LLC initiated a recall of the Aesculap Prospace PEEK 5 degree Implant - 8 x 8.5 x 22 mm (SN038P) because the device is incorrectly etched with an 8 degree lordosis...

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FDA Device Recall: Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cu 2013-03-06

Class II — The bipolar energy did not stop after release of the foot pedal.

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FDA Device Recall: Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Cath 2013-02-20

Class II — The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm mark on the catheter. In some cases the surgeon will want to adjust the defle...

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