Recall Register

Aesculap Inc: FDA recalls

FDA enforcement reports name Aesculap Inc as the recalling firm in 25 events. The events have 40 product records. The recalls started from 2012 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

25 events, newest first.

FDA enforcement events of Aesculap Inc
InitiatedProduct (first record)TypeClassRecordsStatus
15 Jan 2026Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/ADeviceClass II1Ongoing
24 Sep 2025Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/ADeviceClass II4Ongoing
31 Jan 2025Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R, Phaneuf Hysterectomy Forceps ANG 205MM; (3) REF BJ511R, Holzbach Hyst Forceps CVD245MM; (4) REF BJ520R, Heaney Hyst Forceps Grooved 205MM; (5) REF BJ521R, Heaney Hyst Forceps Grooved 250MM; (6)…DeviceClass II5Ongoing
13 May 2024Aeos Robotic Digital Microscope, Product Code: PV010DeviceClass II1Ongoing
9 Jan 2024DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.DeviceClass II5Ongoing
29 Dec 2023MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";DeviceClass II2Ongoing
30 Nov 2015Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint.DeviceClass II1Terminated
17 Nov 2015Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery.DeviceClass II1Terminated
10 Nov 2015Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.DeviceClass II4Terminated
7 Jul 2015S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipital plate/transverse connector and other connectors.DeviceClass II1Terminated
17 Dec 2014Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.DeviceClass II1Terminated
11 Nov 2014Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.DeviceClass III1Terminated
24 Oct 2014The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.DeviceClass II1Terminated
13 Jun 2014Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 suturesDeviceClass II1Terminated
21 Apr 2014Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.DeviceClass II1Terminated
23 Dec 2013Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.DeviceClass II1Terminated
9 Dec 2013Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN and microspeed motor systems to hold burrs which cut and shape bone.DeviceClass II1Terminated
20 Sep 2013Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)DeviceClass II1Terminated
19 Sep 2013Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7DeviceClass II1Terminated
10 Sep 2013Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.DeviceClass II1Terminated
16 Jul 2013UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.DeviceClass II1Terminated
18 Jun 2013ProSpace 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 the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total…DeviceClass II1Terminated
18 Jan 2013Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.DeviceClass II1Terminated
4 Jun 2012Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.DeviceClass II1Terminated
9 May 2012Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Aesculap Inc: events for each product type
TypeEvents
Device25
Aesculap Inc: events in each class
ClassEvents
Class II24
Class III1
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
6

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Aesculap Inc, by the year that the recall started. The largest year is 2013, with 8 events.

Official channels

Cite this page

Recall Register. Aesculap Inc: FDA recalls. https://recallregister.com/firm/aesculap-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
PA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Aesculap Inc have?
Class II: 24 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Aesculap Inc?
FDA event 98301, which the firm started on 15 Jan 2026. The first product in the record is: Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/A
How many FDA recalls of Aesculap Inc have the status Ongoing?
6 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.