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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 15 of 310

Device	Model / Reference	Registries	Class	Status
Aesculap	MG887R	FDA UDI	Class I	Active
Aesculap	MG640R	FDA UDI	Class I	Active
Aesculap	OG128R	FDA UDI	Class I	Unknown
Prospace®	SN024P	FDA UDI	Class II	Unknown
S4 Cervical	SW144T	FDA UDI	Class II	Active
Aesculap	MN228R	FDA UDI	Class II	Active
Aesculap	FG478T	FDA UDI	Class II	Active
Aesculap	PM618R	FDA UDI	Class II	Active
Aesculap	MA002R	FDA UDI	Class I	Active
Aesculap	MA501R	FDA UDI	Class II	Active
Progav 2.0	FX606T	FDA UDI	Class II	Active
Progav 2.0	FX382T	FDA UDI	Class II	Active
Ennovate	SZ297R	FDA UDI	Class I	Active
Aesculap	MB380R	FDA UDI	Class II	Active
Columbus	NE379R	FDA UDI	Class I	Unknown
Aesculap	FF665R	FDA UDI	Class I	Active
Aesculap	LX210R	FDA UDI	Class I	Active
Columbus® UC	NN440	FDA UDI	Class II	Active
Susi	BH111SU	FDA UDI	Class I	Unknown
Progav 2.0	FX653T	FDA UDI	Class II	Active
Elan 4	MD756	FDA UDI	Class I	Active
Aesculap	MA508R	FDA UDI	Class I	Unknown
Aesculap	MA588R	FDA UDI	Class I	Active
A-Space Sibd	SJ632P	FDA UDI	Class II	Unknown
Macs Tl	SX827T	FDA UDI	Class II	Active
Sse	SX100T	FDA UDI	Class II	Unknown
Aesculap	PM612R	FDA UDI	Class II	Active
Aesculap	BA723	FDA UDI	Class I	Active
Aesculap	FK724R	FDA UDI	Class I	Active
Atractor	FC511R	FDA UDI	Class I	Active
Hydrolift	SV005T	FDA UDI	Class II	Unknown
Aesculap	FK672R	FDA UDI	Class I	Active
Prospace®	SN013P	FDA UDI	Class II	Unknown
Aesculap	DE631R	FDA UDI	Class I	Unknown
Tspace® Peek	FJ693P	FDA UDI	Class II	Active
Excia®	NK690K	FDA UDI	Class II	Unknown
S4 Cervical	SX465T	FDA UDI	Class II	Active
Aesculap	EK110SU	FDA UDI	Class II	Active
Aesculap	BH183R	FDA UDI	Class I	Active
VEGA System® PS	NX101	FDA UDI	Class II	Active
Atraumata	FC323T	FDA UDI	Class I	Active
Aesculap	EK051R	FDA UDI	Class II	Active
Enduro	NB027K	FDA UDI	Class II	Unknown
Aesculap	MG643R	FDA UDI	Class I	Active
Tspace	ME927R	FDA UDI	Class I	Active
Diadust	FM585R	FDA UDI	Class I	Active
Aesculap	FL401R	FDA UDI	Class I	Active
Atraumata	FB734R	FDA UDI	Class I	Active
Aesculap	NR442K	FDA UDI	Class II	Unknown
Aesculap	PO141R	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