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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 12 of 310

Device	Model / Reference	Registries	Class	Status
Aesculap	PM147R	FDA UDI	Class II	Active
Ennovate C	SQ168TS	FDA UDI	Class II	Active
Ennovate	SZ247R	FDA UDI	Class I	Unknown
Aesculap	MD546R	FDA UDI	Class I	Active
Metha® MONO	NC295T	FDA UDI	Class II	Active
As Enduro	NB068Z	FDA UDI	Class II	Active
Ennovate C	SZ018R	FDA UDI	Class II	Active
Aesculap	US929	FDA UDI	Class I	Active
Aesculap	FK953R	FDA UDI	Class I	Unknown
Columbus® REVISION F	NR632M	FDA UDI	Class II	Active
Noir	FD706B	FDA UDI	Class I	Active
Minop	FH606SU	FDA UDI	Class I	Active
Aesculap	SW432T	FDA UDI	Class II	Unknown
Arcadius Xp C	US220R	FDA UDI	Class I	Active
Aesculap	MG520R	FDA UDI	Class I	Active
Aesculap	FW227R	FDA UDI	Class I	Active
Diadust	FM530R	FDA UDI	Class I	Active
Aesculap	MD465R	FDA UDI	Class I	Active
Quintex	SC514T	FDA UDI	Class II	Active
Aesculap	JG910	FDA UDI	Class I	Unknown
Aesculap	SW334T	FDA UDI	Class II	Unknown
Resource	BM002ZR	FDA UDI	Class I	Active
Aesculap	MN202R	FDA UDI	Class II	Active
Aesculap	GF471R	FDA UDI	Class II	Active
Aesculap	SQ164TS	FDA UDI	Class II	Active
Aesculap	US412SU	FDA UDI	Class II	Active
Aesculap	MF495R	FDA UDI	Class I	Active
Columbus Ps	NS114R	FDA UDI	Class I	Unknown
Aesculap	BB074US	FDA UDI	Class I	Active
Aesculap	PO742R	FDA UDI	Class II	Active
Cespace	FJ356R	FDA UDI	Class I	Active
Aesculap	DE114R	FDA UDI	Class I	Active
Aesculap	BC326R	FDA UDI	Class I	Active
Aesculap	EA107R	FDA UDI	Class I	Active
Aesculap	DE293R	FDA UDI	Class I	Active
Aesculap	MF286R	FDA UDI	Class I	Active
Aesculap	GA391SU	FDA UDI	Class I	Active
Aesculap	MG052R	FDA UDI	Class II	Active
Excia® L	NK601T	FDA UDI	Class II	Active
Aesculap	PO011R	FDA UDI	Class II	Active
Aesculap	BV338R	FDA UDI	Class I	Active
Aesculap	OM521R	FDA UDI	Class I	Unknown
Biolox® Option	NK537	FDA UDI	Class II	Active
Aesculap	BC685R	FDA UDI	Class II	Active
Aesculap	FT662T	FDA UDI	Class II	Active
Aesculap	FE764K	FDA UDI	Class II	Active
Aesculap	MB924R	FDA UDI	Class I	Active
Aesculap	MB544	FDA UDI	Class I	Active
Gav 2.0	FX212T	FDA UDI	Class II	Active
Aesculap	NQ340	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