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AESCULAP, INC.

Last updated September 17, 2026

Information

Country: US
Address: 3773 CORPORATE PKWY., CENTER VALLEY, PA, 18034
Website: bbraun.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)282-9000
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2916714
DUNS Number: 082594540

Catalogue (15470)

Page 2 of 310

Device	Model / Reference	Registries	Class	Status
Aesculap	BF431US	FDA UDI	Class I	Active
Columbus® REVISION	NR242K	FDA UDI	Class II	Unknown
Columbus® REVISION F	NR017K	FDA UDI	Class II	Unknown
Excia T	NT938R	FDA UDI	Class I	Active
A-Space Sibd	SJ760P	FDA UDI	Class II	Unknown
Aesculap	BD030R	FDA UDI	Class I	Active
Aesculap	ND912	FDA UDI	Class I	Unknown
Columbus® CR	NN930K	FDA UDI	Class II	Active
Columbus® REVISION	NR048K	FDA UDI	Class II	Unknown
Metha®	NC099K	FDA UDI	Class II	Unknown
Aesculap	FF136R	FDA UDI	Class II	Active
Aesculap	MA754R	FDA UDI	Class I	Active
Aesculap	GF046B	FDA UDI	Class II	Active
Activ L	ME568R	FDA UDI	Class I	Active
Aesculap	MB621R	FDA UDI	Class I	Active
Aicon	JJ726	FDA UDI	Class II	Active
As Enduro	NB045Z	FDA UDI	Class II	Active
Aesculap	MG637R	FDA UDI	Class I	Active
Sq.line	MB193R	FDA UDI	Class I	Active
Aesculap	MF059R	FDA UDI	Class I	Active
Columbus® CR DD	NN1221	FDA UDI	Class II	Active
Aesculap	SX638T	FDA UDI	Class II	Unknown
Metha®	NC079K	FDA UDI	Class II	Unknown
Columbus® CR	NN830K	FDA UDI	Class II	Active
Columbus® REVISION F	NR127M	FDA UDI	Class II	Active
Aesculap	NQ044T	FDA UDI	Class II	Active
Aesculap	FF751R	FDA UDI	Class I	Active
Columbus	NQ887R	FDA UDI	Class I	Active
Aesculap	NQ142	FDA UDI	Class II	Unknown
Elan 4	MD870	FDA UDI	Class I	Active
Isodur®	NK670K	FDA UDI	Class II	Active
Aesculap	US136	FDA UDI	Class I	Active
AS Columbus® REVISION F	NR013Z	FDA UDI	Class II	Active
Aesculap	MB909R	FDA UDI	Class I	Active
Columbus® REVISION F	NR111M	FDA UDI	Class II	Active
Aesculap	MD391R	FDA UDI	Class I	Active
Progav 2.0	FX670T	FDA UDI	Class II	Active
Aesculap	FF717R	FDA UDI	Class I	Active
Gav 2.0	FX246T	FDA UDI	Class II	Active
VEGA System® PS	NX343	FDA UDI	Class II	Active
VEGA System® PS	NX058K	FDA UDI	Class II	Unknown
Aesculap	US585	FDA UDI	Class II	Active
Aesculap	SW343T	FDA UDI	Class II	Unknown
Ennovate C	SQ060TS	FDA UDI	Class II	Active
Ennovate C	SQ650TS	FDA UDI	Class II	Active
Mininav	FV693T	FDA UDI	Class II	Active
Aesculap	FT284T	FDA UDI	Class II	Active
Elan 4	US795SU	FDA UDI	Class II	Active
Aesculap	MB775R	FDA UDI	Class I	Active
Columbus®	NN592K	FDA UDI	Class II	Active

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FDA Recalls (44)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 15, 2026	Z-1485-2026	—	open, classified	There is the potential for the length of the trocar shaft to be too long.
Sep 24, 2025	Z-0311-2026	—	open, classified	It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Sep 24, 2025	Z-0310-2026	—	open, classified	It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Sep 24, 2025	Z-0309-2026	—	open, classified	It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Sep 24, 2025	Z-0312-2026	—	open, classified	It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Jan 31, 2025	Z-1308-2025	—	open, classified	The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Jan 31, 2025	Z-1309-2025	—	open, classified	The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Jan 31, 2025	Z-1310-2025	—	open, classified	The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Jan 31, 2025	Z-1312-2025	—	open, classified	The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Jan 31, 2025	Z-1311-2025	—	open, classified	The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
May 13, 2024	Z-2139-2024	—	open, classified	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.
Jan 9, 2024	Z-1246-2024	—	open, classified	The sterile blister packaging may be damaged, and sterility may be compromised.
Jan 9, 2024	Z-1244-2024	—	open, classified	The sterile blister packaging may be damaged, and sterility may be compromised.
Jan 9, 2024	Z-1245-2024	—	open, classified	The sterile blister packaging may be damaged, and sterility may be compromised.
Jan 9, 2024	Z-1247-2024	—	open, classified	The sterile blister packaging may be damaged, and sterility may be compromised.
Jan 9, 2024	Z-1243-2024	—	open, classified	The sterile blister packaging may be damaged, and sterility may be compromised.
Dec 29, 2023	Z-0866-2024	—	open, classified	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.
Dec 29, 2023	Z-0867-2024	—	open, classified	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.
Nov 30, 2015	Z-1043-2016	—	terminated	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.
Nov 17, 2015	Z-0566-2016	—	terminated	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
Nov 10, 2015	Z-0448-2016	—	terminated	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.
Nov 10, 2015	Z-0424-2016	—	terminated	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.
Nov 10, 2015	Z-0423-2016	—	terminated	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.
Nov 10, 2015	Z-0422-2016	—	terminated	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.
Jul 7, 2015	Z-2326-2015	—	terminated	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.
Dec 17, 2014	Z-1012-2015	—	terminated	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).
Nov 11, 2014	Z-0814-2015	—	terminated	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.
Oct 24, 2014	Z-0502-2015	—	terminated	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 this issue.
Jun 13, 2014	Z-2024-2014	—	terminated	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.
Apr 21, 2014	Z-1676-2014	—	terminated	AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.
Dec 23, 2013	Z-0989-2014	—	terminated	The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.
Dec 9, 2013	Z-0623-2014	—	terminated	Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece.
Sep 20, 2013	Z-0361-2014	—	terminated	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.
Sep 19, 2013	Z-0492-2014	—	terminated	The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.
Sep 10, 2013	Z-0479-2014	—	terminated	Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.
Jul 16, 2013	Z-0031-2014	—	terminated	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.
Jun 18, 2013	Z-1806-2013	—	terminated	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.
Jan 18, 2013	Z-0887-2013	—	terminated	The bipolar energy did not stop after release of the foot pedal.
Jun 4, 2012	Z-0805-2013	—	terminated	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
May 9, 2012	Z-0082-2013	—	terminated	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.
Jul 19, 2011	Z-3014-2011	—	terminated	Aesculap Implant Systems received a notification from the manufacturer, Aesculap, AG of a fractured CoCr neck adapter.
Nov 22, 2010	Z-1474-2011	—	terminated	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.
Nov 1, 2007	Z-0709-2008	—	terminated	Breakage: the inner rod of the applier may corrode and break
Nov 1, 2007	Z-0708-2008	—	terminated	Breakage: the inner rod of the applier may corrode and break