Aesculap recalls
Aesculap appears in 40 official U.S. recall notices indexed by RecallRadar, most recently on 2026-03-11.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 40 |
|---|---|
| Published | 2012-10-24 to 2026-03-11 |
| By agency | FDA Device (40) |
| By classification | Class II (39), Class III (1) |
| By status | terminated (22), ongoing (18) |
| Distribution named in notices | AZ, CT, DE, FL, GA, IL, KS, KY, MA, MD, MI, MN, NV, NY, OK, PA, RI, SC, TN, TX, US, WA, WI |
Recalls
- Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Descr…
FDA Device · Class II · 2026-03-11 · Aesculap
Reason: There is the potential for the length of the trocar shaft to be too long. - Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Desc…
FDA Device · Class II · 2025-11-05 · Aesculap
Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. - Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description:…
FDA Device · Class II · 2025-11-05 · Aesculap
Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. - Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description:…
FDA Device · Class II · 2025-11-05 · Aesculap
Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. - Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description…
FDA Device · Class II · 2025-11-05 · Aesculap
Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. - Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM
FDA Device · Class II · 2025-03-19 · Aesculap
Reason: The forceps have been used in ways not covered by the design resulting in breakage of the clamps. - Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM
FDA Device · Class II · 2025-03-19 · Aesculap
Reason: The forceps have been used in ways not covered by the design resulting in breakage of the clamps. - Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM
FDA Device · Class II · 2025-03-19 · Aesculap
Reason: The forceps have been used in ways not covered by the design resulting in breakage of the clamps. - Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM
FDA Device · Class II · 2025-03-19 · Aesculap
Reason: The forceps have been used in ways not covered by the design resulting in breakage of the clamps. - Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM
FDA Device · Class II · 2025-03-19 · Aesculap
Reason: The forceps have been used in ways not covered by the design resulting in breakage of the clamps. - Aeos Robotic Digital Microscope, Product Code: PV010
FDA Device · Class II · 2024-06-19 · Aesculap
Reason: 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. - DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures
FDA Device · Class II · 2024-03-13 · Aesculap
Reason: The sterile blister packaging may be damaged, and sterility may be compromised. - DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures
FDA Device · Class II · 2024-03-13 · Aesculap
Reason: The sterile blister packaging may be damaged, and sterility may be compromised. - DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures
FDA Device · Class II · 2024-03-13 · Aesculap
Reason: The sterile blister packaging may be damaged, and sterility may be compromised. - DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures
FDA Device · Class II · 2024-03-13 · Aesculap
Reason: The sterile blister packaging may be damaged, and sterility may be compromised. - DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures
FDA Device · Class II · 2024-03-13 · Aesculap
Reason: The sterile blister packaging may be damaged, and sterility may be compromised. - MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM"
FDA Device · Class II · 2024-02-07 · Aesculap
Reason: 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 procedure. - MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
FDA Device · Class II · 2024-02-07 · Aesculap
Reason: 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 procedure. - Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for…
FDA Device · Class II · 2016-03-09 · Aesculap
Reason: 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 as Cementless. US product is i… - Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery
FDA Device · Class II · 2016-01-06 · Aesculap
Reason: AAG received a customer complaint that corrosion had been found by a hospitals central sterile service department on the ball joint of an FC424R blade. Investigation revealed that the corrosion was due to incorrect mat… - Flexible Bone Awl
FDA Device · Class II · 2015-12-30 · Aesculap
Reason: 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. - Flexible Drill
FDA Device · Class II · 2015-12-30 · Aesculap
Reason: 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. - Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amou…
FDA Device · Class II · 2015-12-30 · Aesculap
Reason: 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. - Flexible Screw Driver SJ706R
FDA Device · Class II · 2015-12-30 · Aesculap
Reason: 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. - S4C Occiput Torque Wrench F/Set Screw
FDA Device · Class II · 2015-08-12 · Aesculap
Reason: 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 reassembly after reprocessing. - Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventric…
FDA Device · Class II · 2015-02-04 · Aesculap
Reason: 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. The product is MR unsafe. This i… - Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral vent…
FDA Device · Class III · 2014-12-24 · Aesculap
Reason: 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 issue. - The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus
FDA Device · Class II · 2014-12-10 · Aesculap
Reason: Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to incorrect product labeling on three units. The incorrect product labeling was the wrong expiration date, 2024-09, on the in… - Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box s…
FDA Device · Class II · 2014-07-16 · Aesculap
Reason: 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 do state non-sterile; however th… - Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospi…
FDA Device · Class II · 2014-06-11 · Aesculap
Reason: AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter. - Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the la…
FDA Device · Class II · 2014-02-26 · Aesculap
Reason: The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L. - Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems to hold burrs which cut and sha…
FDA Device · Class II · 2014-01-15 · Aesculap
Reason: Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece. - Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7
FDA Device · Class II · 2013-12-25 · Aesculap
Reason: The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible. - Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical p…
FDA Device · Class II · 2013-12-18 · Aesculap
Reason: Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control. - Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
FDA Device · Class II · 2013-11-27 · Aesculap
Reason: 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. - UNITRAC Pneumatic Retraction Arm
FDA Device · Class II · 2013-10-30 · Aesculap
Reason: 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 RT… - ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in…
FDA Device · Class II · 2013-07-31 · Aesculap
Reason: 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 lordosi… - Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation
FDA Device · Class II · 2013-03-06 · Aesculap
Reason: The bipolar energy did not stop after release of the foot pedal. - Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide…
FDA Device · Class II · 2013-02-20 · Aesculap
Reason: 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… - Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
FDA Device · Class II · 2012-10-24 · Aesculap
Reason: 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 markin…