Aesculap Recalls
40 recalls on record · October 24, 2012 to March 11, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 26, 2014Medical DevicesFDA
Aesculap, Inc. recalls Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrosp
Hazard: The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.
January 15, 2014Medical DevicesFDA
Aesculap, Inc. recalls Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems to hold b
Hazard: Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece.
December 25, 2013Medical DevicesFDA
Aesculap, Inc. recalls Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7
Hazard: The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.
December 18, 2013Medical DevicesFDA
Aesculap, Inc. recalls Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery t
Hazard: Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.
November 27, 2013Medical DevicesFDA
Aesculap, Inc. recalls Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
Hazard: 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.
October 30, 2013Medical DevicesFDA
Aesculap, Inc. recalls UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Hazard: 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 new Quick Release Coupling RT02OR to eliminate the need to sterilize the UNITRAC and a functional check was added prior to use to ensure optimal functionality of the UNITRAC system.
July 31, 2013Medical DevicesFDA
Aesculap, Inc. recalls ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral
Hazard: 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 instead of a 5 degree lordosis. The device is labeled correctly, only the etching of the implant may be incorrect.
March 6, 2013Medical DevicesFDA
Aesculap, Inc. recalls Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
Hazard: The bipolar energy did not stop after release of the foot pedal.
February 20, 2013Medical DevicesFDA
Aesculap, Inc. recalls Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Styl
Hazard: 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 deflector to a different location on the catheter before placing it in the ventricle. There is a small percentage of cases where aggressively attempting to adjust the deflector has a potential to cause the catheter
October 24, 2012Medical DevicesFDA
Aesculap, Inc. recalls Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
Hazard: The manufacturer informed the recalling firm of a potential laser marking error in size identification on two Columbus 4-IN-1 Femoral Cutting Guide Instruments. The guides are correctly dimensioned, but the laser markings have been incorrectly etched.