RegWardenFDA facility compliance records
Facility

AESCULAP, INC.

26 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2012: 2 recalls; 2013: 8 recalls; 2014: 5 recalls; 2015: 4 recalls; 2016: 1 inspections; 2018: 1 inspections; 2023: 1 recalls; 2024: 2 recalls; 2025: 3 recalls; 2026: 1 recalls2’128’135’144’151’16’171’18’19’20’21’221’232’243’251’26
  • Recalls (26)
  • Inspections (2)

Devices registered here (1)

Recalls & enforcement

20261 record
20253 records
  • Class IIOngoing2025-09-24
    It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
  • Class IIOngoing2025-08-18
    Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
  • Class IIOngoing2025-01-31
    The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
20242 records
  • Class IIOngoing2024-05-13
    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.
  • Class IIOngoing2024-01-09
    The sterile blister packaging may be damaged, and sterility may be compromised.
20231 record
  • Class IIOngoing2023-12-29
    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.
20154 records
  • Class IITerminated2015-11-30
    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 indicated in the US for use with Bone Cement only.
  • Class IITerminated2015-11-17
    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 material used in the manufacturing of the disk spring of the bal…
  • Class IITerminated2015-11-10
    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.
  • Class IITerminated2015-07-07
    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.
20145 records
  • Class IITerminated2014-12-17
    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 information is only required to be in the Instructions for Use…
  • Class IIITerminated2014-11-11
    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.
  • Class IITerminated2014-10-24
    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 inner labeling of the sterile bag. However, the expiration da…
  • Class IITerminated2014-06-13
    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 there is an additional label that is affixed on the box that s…
  • Class IITerminated2014-04-21
    AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.
20138 records
  • Class IITerminated2013-12-23
    The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.
  • Class IITerminated2013-12-09
    Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece.
  • Class IITerminated2013-09-20
    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.
  • Class IITerminated2013-09-19
    The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.
  • Class IITerminated2013-09-10
    Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.
  • Class IITerminated2013-07-16
    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 fun…
  • Class IITerminated2013-06-18
    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 i…
  • Class IITerminated2013-01-18
    The bipolar energy did not stop after release of the foot pedal.
20122 records
  • Class IITerminated2012-06-04
    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 …
  • Class IITerminated2012-05-09
    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.

FDA inspections (2)

  • VAI2018-06-13
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • VAI2016-09-14
    Voluntary Action Indicated · Compliance: Devices; Project Evaluation: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “AESCULAP, INC. (FEI 3003587896) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003587896-aesculap-inc/

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