Data / Medical devices / United States / Aesculap, Inc.
Aesculap, Inc.: FDA-registered device maker in Center Valley, PA, United States, 144 510(k) clearances
Aesculap, Inc. is registered with the FDA (registration 2916714) in Center Valley, PA, United States. It lists 318 device types. The FDA files 144 510(k) clearances under its listings, the newest dated October 2, 2026. 66 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2916714
- Address
- 3773 Corporate Pkwy., Center Valley, PA, United States, 18034
- Owner or operator
- AESCULAP, INC. (2916714)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 27, 1989
- Registered through
- 2027
- Brand names listed
- ,AC-POWERED MOTOR AND ACCESSORY, AESCULAP, AESCULAP GRASPER, AND THROAT, ARTHROSCOPIC ACCESSORIES, ATTACHMENT, ATTACHMENTS, Aesculap and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 144.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 2, 2026 | K260044 | Ventricular Catheters, Thomale Catheter | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| December 16, 2024 | K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| June 29, 2023 | K223596 | SQ.line KERRISON | HAE | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| December 13, 2021 | K211572 | Aesculap Slim Clip Applier | HCI | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| August 24, 2021 | K203739 | ELAN 4 Electro Motor System | HBE | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| January 21, 2021 | K202391 | DIR 800 | IZI | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| December 18, 2020 | K203461 | Aesculap Caiman 12 Seal and Cut Technology System | GEI | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| May 8, 2020 | K200950 | Ventricular Catheter | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| March 27, 2020 | K192056 | JJ Series Container System | KCT | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| March 17, 2020 | K193582 | SterilContainer S2 System | KCT | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| November 27, 2019 | K190811 | Optimus NEURO System - Sterile Kit | GWO | Substantially Equivalent | Osteonic Co., Ltd. | accessdata.fda.gov |
| November 21, 2019 | K192266 | M. Blue Adjustable Shunt System | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| August 9, 2019 | K183203 | ELAN 4 Tools | HBE | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| July 5, 2019 | K190174 | Miethke Shunt System GAV 2.0 and SA 2.0 Valves | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| July 5, 2019 | K182414 | Aesculap® SterilContainer(TM) S2 System | KCT | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| March 12, 2019 | K183180 | Caiman 5 Maryland | GEI | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| January 19, 2019 | K182527 | ELAN 4 Tools | HBE | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| January 2, 2019 | K183352 | Optimus Neuro System | GWO | Substantially Equivalent | Osteonic Co., Ltd. | accessdata.fda.gov |
| December 21, 2018 | K182032 | SterilContainer S System | KCT | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| November 9, 2018 | K172907 | ELAN 4 Air Motor System | HBB | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| October 17, 2018 | K172709 | ELAN 4 Electro Motor System Tools | HBE | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| May 8, 2018 | K172661 | Fetzer Medical Gynecological Forceps | HCZ | Substantially Equivalent | Fetzer Medical GmbH & Co. KG | accessdata.fda.gov |
| April 17, 2018 | K180914 | Aesculap Slim Clip Applier | HCI | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| February 20, 2018 | K170683 | Aesculap Video Assisted Thoracic Surgery (VATS) INstruments | GCJ | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| December 27, 2017 | K171037 | PoreStar Patient Specific Implant | JOF | Substantially Equivalent | Anatomics Pty, Ltd. | accessdata.fda.gov |
| November 17, 2017 | K172850 | SterilContainer with PrimeLine Pro Lid | KCT | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| November 10, 2017 | K173271 | Aesculap Slim Clip Applier Forceps | HCI | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| July 13, 2017 | K162815 | SterilContainer S System | KCT | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| June 29, 2017 | K163524 | Vessel Dilator | DWP | Substantially Equivalent | Fetzer Medical GmbH & Co. KG | accessdata.fda.gov |
| February 27, 2017 | K161853 | proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| September 9, 2016 | K161004 | Self-retaining Retractor | GZT | Substantially Equivalent | Fetzer Medical GmbH & Co. KG | accessdata.fda.gov |
| July 22, 2016 | K152960 | ELAN 4 Motor System | HBC | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| May 26, 2016 | K160393 | AdTec | GCJ | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| February 29, 2016 | K150468 | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | HAE | Substantially Equivalent | K2 Medical GmbH & Co. KG | accessdata.fda.gov |
| October 9, 2015 | K151242 | SterilContainer S | KCT | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| August 18, 2015 | K143729 | SterilContainer S | KCT | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| July 29, 2015 | K150377 | Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor | GCJ | Substantially Equivalent | Sony Electronics, Inc. | accessdata.fda.gov |
| July 21, 2015 | K151858 | Caiman Seal and Cut Technology | GEI | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| July 20, 2015 | K151696 | Caiman Seal and Cut Technology | GEI | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| July 8, 2015 | K142970 | SterilContainer S System | KCT | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| April 2, 2015 | K141687 | AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| February 10, 2015 | K141911 | OPTIMUS NEURO SYSTEM | GWO | Substantially Equivalent | Osteonic Co., Ltd. | accessdata.fda.gov |
| November 24, 2014 | K140566 | SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE | JOJ | Substantially Equivalent | Crosstex International | accessdata.fda.gov |
| November 14, 2014 | K142315 | MINOP Disposable Introducer 26F | GWG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| January 24, 2014 | K131500 | YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS | HCH | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| June 4, 2013 | K122791 | LYOPLANT ONLAY | GXQ | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| March 22, 2013 | K130596 | CAIMAN SEAL AND CUT TECHNOLOGY | GEI | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| August 30, 2012 | K122353 | CRAINFIX 2 TITANIUM CLAMP SYSTEM | GXN | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| May 24, 2012 | K120559 | AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| May 4, 2012 | K112671 | STERILCONTAINER SYSTEM | KCT | Substantially Equivalent | Aesculap, Ltd. | accessdata.fda.gov |
| April 30, 2012 | K120492 | K2 MEDICAL VASCULAR CLAMPS | DXC | Substantially Equivalent | K2 Medical GmbH & Co. KG | accessdata.fda.gov |
| October 27, 2011 | K110206 | AESCULAP- MEITHKE SHUNT SYSTEM | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| August 19, 2011 | K111441 | UNIMAX VERESS NEEDLE | HIF | Substantially Equivalent | Unimax Medical Systems, Inc. | accessdata.fda.gov |
| June 28, 2011 | K110695 | BIPOLAR HF DEVICE | GEI | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| April 15, 2011 | K110152 | SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS | JOJ | Substantially Equivalent | Spsmedical Supply Corp. | accessdata.fda.gov |
| November 9, 2010 | K103003 | AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| August 6, 2010 | K102081 | ENDOSCOPIC CLIP SYSTEM | FZP | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| July 27, 2010 | K093493 | AESCULAP STERILCONTAINER S | FRG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| May 11, 2010 | K093649 | AESCULAP STERILCONTAINER S | FRG | Substantially Equivalent | Aesculap | accessdata.fda.gov |
| December 3, 2009 | K092840 | INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL | HCZ | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| May 5, 2008 | K081031 | ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE | FZP | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| April 28, 2008 | K073168 | AESCULAP PRIMELINE CONTAINER LTD. | KCT | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| April 2, 2008 | K080753 | AESCULAP ENDOSCOPIC CLIP SYTEM | FZP | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| January 17, 2007 | K062009 | AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| November 21, 2006 | K062413 | AESCULAP PNEUMATIC KERRISON | HAD | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| November 17, 2006 | K062510 | AESCULAP STERILCONTAINER SYSTEM | FRG | Substantially Equivalent | Aesculap | accessdata.fda.gov |
| July 19, 2006 | K060233 | TROKAMED GMBH ENDOSCOPES AND ACCESSORIES | GCJ | Substantially Equivalent | Trokamed GmbH | accessdata.fda.gov |
| July 11, 2006 | K061135 | MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019 | GWG | Substantially Equivalent | Aesculap | accessdata.fda.gov |
| April 7, 2006 | K060492 | AESCULAP CRANIOFACIAL PLATE AND SCREW | JEY | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| February 15, 2006 | K053389 | AESCULAP STERILCONTAINER SYSTEM | FRG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| January 18, 2006 | K053526 | MICROSPEED UNI MOTOR SYSTEM | HBC | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| December 13, 2004 | K041623 | REUSABLE STERILCONTAINER FILTER MODEL #JK090 | FRG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| December 9, 2004 | K043041 | AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) | HCH | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| December 6, 2004 | K040865 | AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER | FRG | Substantially Equivalent | Aesculap | accessdata.fda.gov |
| June 17, 2004 | K040864 | CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM | GXN | Substantially Equivalent | Aesculap | accessdata.fda.gov |
| March 31, 2004 | K040080 | AESCULAP ABSORBABLE CRANIOFIX | GXR | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| August 20, 2003 | K032198 | AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP | HCH | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| June 4, 2003 | K031303 | AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV) | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| March 24, 2003 | K024349 | AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER | HCH | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| March 20, 2003 | K030698 | AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| September 6, 2002 | K021931 | ENDOSCOPIC FIBEROPTIC CABLE | HBI | Substantially Equivalent | Gulf Medical Fiberoptics | accessdata.fda.gov |
| April 5, 2002 | K020728 | MIETHKE SHUNT SYSTEM | HCA | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| March 21, 2002 | K014207 | REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083 | GEI | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| March 18, 2002 | K014149 | PAEDISCOPE, MODEL # P010A AND PF011A | GWG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| March 1, 2002 | K011030 | AESCULAP -MIETHKE SHUNT SYSTEM | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| October 3, 2001 | K012986 | BIPOLAR IRRIGATION FORCEPS | GEI | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| July 31, 2001 | K012219 | SCALPFIX CLIP SYSTEM | HBO | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| June 28, 2001 | K003759 | AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR | GWM | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| June 11, 2001 | K010752 | AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY | KNF | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| April 27, 2001 | K003740 | MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION | HRX | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| February 20, 2001 | K003612 | MICROSPEED EC MOTORSYSTEM GD650/GD653 | HBC | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| February 20, 2001 | K003608 | SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY | HGI | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| October 13, 2000 | K002871 | MODIFICATION TO YASARGIL ANEURYSM CLIPS | HCH | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| May 30, 2000 | K001330 | SOVEREIGN BIPOLAR INSTRUMENTS | GEI | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| January 13, 2000 | K992053 | AESCULAP VASCULAR INSTRUMENTS | DXC | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| July 30, 1999 | K992218 | DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601 | GEI | Substantially Equivalent | Kirwan Surgical Products, Inc. | accessdata.fda.gov |
| May 28, 1999 | K991088 | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| February 1, 1999 | K984124 | AESCULAP XENON LIGHT SOURCE | FSS | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| December 18, 1998 | K983758 | YASARGIL TITANIUM ANEURYSM CLIPS | HCH | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| December 18, 1998 | K983365 | AESCULAP MINOP SYSTEM | GWG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 15, 2026 | 98301 | Class II | Ongoing | 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 | There is the potential for the length of the trocar shaft to be too long. | accessdata.fda.gov |
| September 24, 2025 | 97649 | Class II | Ongoing | Brand 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/A | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. | accessdata.fda.gov |
| January 31, 2025 | 96223 | Class II | Ongoing | Numerous 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 BJ | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | accessdata.fda.gov |
| May 13, 2024 | 94623 | Class II | Ongoing | Aeos Robotic Digital Microscope, Product Code: PV010 | 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. | accessdata.fda.gov |
| January 9, 2024 | 93856 | Class II | Ongoing | DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures. | The sterile blister packaging may be damaged, and sterility may be compromised. | accessdata.fda.gov |
| December 29, 2023 | 93793 | Class II | Ongoing | MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM" | 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. | accessdata.fda.gov |
| July 20, 2023 | 92813 | Class II | Ongoing | For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R | Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30 neuroendoscope, a portion of the visual field is obscured. | accessdata.fda.gov |
| May 18, 2023 | 92575 | Class II | Ongoing | Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610 | Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610. | accessdata.fda.gov |
| March 21, 2023 | 92079 | Class II | Ongoing | Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended | Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body. | accessdata.fda.gov |
| February 23, 2023 | 91968 | Class II | Ongoing | Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many me | Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607. | accessdata.fda.gov |
| July 15, 2022 | 90678 | Class II | Ongoing | Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014 | Potential for the incorrect screw to be included in the package. | accessdata.fda.gov |
| July 14, 2022 | 90641 | Class II | Terminated | Aeos Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010 | Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available: | accessdata.fda.gov |
| October 25, 2021 | 90544 | Class II | Terminated | MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441 | Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant. | accessdata.fda.gov |
| June 30, 2021 | 90537 | Class II | Terminated | RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery. | Customized coronal rod benders may deform the implant when used with the spinal system devices. | accessdata.fda.gov |
| April 16, 2021 | 88327 | Class II | Terminated | PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU | Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery | accessdata.fda.gov |
| March 19, 2021 | 88325 | Class II | Terminated | Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F MENISCAL COMP.T2 RM/LM 7MM; NL472 UNIVATION F MENISCAL COMP.T3 RM/LM 7MM NL473 UNIVATIO | Malfunction- loosening of the implant resulting in a potential revision surgery | accessdata.fda.gov |
| February 19, 2021 | 90532 | Class II | Completed | Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010 | Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system. | accessdata.fda.gov |
| November 18, 2020 | 90526 | Class II | Terminated | ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R | Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key. | accessdata.fda.gov |
| September 8, 2020 | 90502 | Class II | Terminated | AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery. | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion. | accessdata.fda.gov |
| July 13, 2020 | 90503 | Class II | Terminated | ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R | Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. | accessdata.fda.gov |
| April 1, 2020 | 90493 | Class II | Completed | PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10 | Endoscopic graspers may become separated at the weld from handle to the shaft of the device. | accessdata.fda.gov |
| January 21, 2020 | 84865 | Class II | Terminated | Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN075K NN076K NN077K NN078K NN079K Product Usage:Tibia-Plateaus are part of implants in the | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. | accessdata.fda.gov |
| November 12, 2019 | 90484 | Class II | Completed | ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery. | Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring. | accessdata.fda.gov |
| October 1, 2019 | 90475 | Class II | Terminated | Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R. | Packaging seal integrity not validated resulting in a lack of sterility assurance. | accessdata.fda.gov |
| September 25, 2019 | 90483 | Class II | Terminated | AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle | Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM. | accessdata.fda.gov |
| August 7, 2019 | 83637 | Class II | Terminated | CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired. | possibility of the sterility batch being insufficiently sterilized | accessdata.fda.gov |
| February 16, 2018 | 79656 | Class III | Terminated | Doyen-Collin Mouth Gag 120MM/ General Instruments | The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable. | accessdata.fda.gov |
| January 22, 2018 | 79530 | Class II | Terminated | DS Titanium Ligation Clip, used in laparoscopic surgery | Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for kidney transplantation with living donors. The information from this publication was not approved or validated by the firm. | accessdata.fda.gov |
| September 21, 2017 | 79093 | Class II | Terminated | proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components | A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure. | accessdata.fda.gov |
| September 8, 2017 | 79089 | Class II | Terminated | JS Series SterilContainer S2 System | The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted by this recall. | accessdata.fda.gov |
| September 5, 2017 | 79068 | Class II | Terminated | ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING ROSEN BURR TC D1.0 ELAN 4 1-RING ROSENBURR+ D1.0 ELAN 4 1-RING ROSEN BURR D1.4 ELAN 4 1-RING ROSENBUR | ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | accessdata.fda.gov |
| September 1, 2017 | 79092 | Class II | Terminated | The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery. | The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. This issue does not affected sales outside the United States (OUS). | accessdata.fda.gov |
| August 10, 2017 | 79042 | Class II | Terminated | NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of | The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is implantation of the incorrect implant size which may lead to injury of ligaments, pain and possible revision surgery. | accessdata.fda.gov |
| March 28, 2017 | 76988 | Class II | Terminated | GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; GP165R; ELAN 4 1-RING DIAM | Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically induced soft tissue damage. | accessdata.fda.gov |
| March 7, 2017 | 76769 | Class II | Terminated | AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and par | Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode. | accessdata.fda.gov |
| January 9, 2017 | 76210 | Class II | Terminated | GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories | Generators may have a faulty component which could impact the proper functioning of the device. | accessdata.fda.gov |
| October 28, 2016 | 75937 | Class II | Terminated | Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries | Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps. | accessdata.fda.gov |
| August 1, 2016 | 75142 | Class II | Terminated | Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture | There is a potential for the needle to detach from the suture thread during surgery. If the needle becomes detached the defective suture will need to be replaced causing the wound to be sutured a second time. | accessdata.fda.gov |
| November 30, 2015 | 72853 | Class II | Terminated | Columbus 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. | 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. | accessdata.fda.gov |
| November 17, 2015 | 72712 | Class II | Terminated | Valve 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 tri | 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 ball joint by the supplier | accessdata.fda.gov |
| November 10, 2015 | 72646 | Class II | Terminated | Flexible 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. | 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. | accessdata.fda.gov |
| July 7, 2015 | 71709 | Class II | Terminated | S4C 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 c | 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. | accessdata.fda.gov |
| December 17, 2014 | 70086 | Class II | Terminated | Miethke 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. | 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 (IFU). | accessdata.fda.gov |
| November 11, 2014 | 69741 | Class III | Terminated | Aesculap 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. | 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. | accessdata.fda.gov |
| October 24, 2014 | 69600 | Class II | Terminated | The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus. | 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 date on the outer box was correct. No patient injuries were reported as a result of | accessdata.fda.gov |
| June 13, 2014 | 68607 | Class II | Terminated | Dafilon 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 sutures | 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 states the product is sterile. | accessdata.fda.gov |
| April 21, 2014 | 68091 | Class II | Terminated | Aesculap 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. | AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter. | accessdata.fda.gov |
| December 23, 2013 | 67174 | Class II | Terminated | Aesculap 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. | The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L. | accessdata.fda.gov |
| December 9, 2013 | 67050 | Class II | Terminated | Aesculap 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. | Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece. | accessdata.fda.gov |
| September 20, 2013 | 66534 | Class II | Terminated | Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US) | 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. | accessdata.fda.gov |
| September 19, 2013 | 66536 | Class II | Terminated | Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7 | The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible. | accessdata.fda.gov |
| September 10, 2013 | 66533 | Class II | Terminated | Aesculap 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 s | Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control. | accessdata.fda.gov |
| July 16, 2013 | 65952 | Class II | Terminated | UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures. | 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 UNIT | accessdata.fda.gov |
| June 18, 2013 | 65703 | Class II | Terminated | 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 the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal I | 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. | accessdata.fda.gov |
| January 18, 2013 | 64407 | Class II | Terminated | Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation. | The bipolar energy did not stop after release of the foot pedal. | accessdata.fda.gov |
| July 25, 2012 | 62842 | Class II | Terminated | Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. F | There is a possibility that the screw channel that holds the rod in place may be out of tolerance. When the depth of the channel is not deep enough, the rod may not be able to provide ample compression on the insert preventing the screw head from locking down to the bone screw. | accessdata.fda.gov |
| July 12, 2012 | 62626 | Class II | Terminated | Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct | The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but the part number etched on the instrument may be incorrect. The 4 degree trial instrument (SJ768T-US) may be marked with the incorrect part number of the 9 degree trail instrument (SJ780T-US) and the 9 degree trial instrument (SJ780T-US) may be marked with the inc | accessdata.fda.gov |
| June 4, 2012 | 63244 | Class II | Terminated | Aesculap(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 flui | 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 h | accessdata.fda.gov |
| May 9, 2012 | 63223 | Class II | Terminated | Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R) | 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. | accessdata.fda.gov |
| March 7, 2012 | 62240 | Class II | Terminated | S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery. | Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument that is part of the S4C Occipital Instrument Set. The instruments may not thread into the screw properly during a revision surgery due to tolerance issues between the two instruments. | accessdata.fda.gov |
| February 21, 2012 | 61332 | Class II | Terminated | Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheuma | During an internal quality inspection, the tibia plateau was found to be out of specification. There is a potential for misalignment between the tibia plateau and attachment of the extension stem. | accessdata.fda.gov |
| January 24, 2012 | 61346 | Not yet classified | Terminated | Quintex Cervical Plating System - Screws. The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability. The Quintex Cervical Screws are available in three different versions: semi-cons | The firm has received complaints that the locking ring that sits in the head of the screw can come out of the screw head when engaged with the screwdriver if the screwdriver is improperly angled. | accessdata.fda.gov |
| July 19, 2011 | 59463 | Not yet classified | Terminated | Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip Stems. Aesculap AG. Intended to replace a hip joint | Aesculap Implant Systems received a notification from the manufacturer, Aesculap, AG of a fractured CoCr neck adapter. | accessdata.fda.gov |
| November 22, 2010 | 57419 | Not yet classified | Terminated | Aesculap MicroSpeed Uni Control Box, Part #GD670 Intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro and Maxillo facial Surgery. | Potential safety issue in that the control box can misinterpret the information sent from the low speed motor if the control magnet inside the motor changes its posthion. | accessdata.fda.gov |
| November 1, 2007 | 46142 | Not yet classified | Terminated | Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper Applier F/Mini Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034 | Breakage: the inner rod of the applier may corrode and break | accessdata.fda.gov |
| October 10, 2007 | 45456 | Not yet classified | Terminated | Excia Cemented Hip Stems, Size 9mm, Part Number: NJ309K, Aesculap Implant Systems, Inc., Center Valley, PA 18034 | Sterility (package integrity) Compromised: Device package damaged during shipment | accessdata.fda.gov |
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Updated October 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.