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AESCULAP, INC.

Last updated September 17, 2026

What AESCULAP, INC. makes

The company manufactures reusable orthopaedic and spinal surgical instruments, including positioning tools for prosthesis implantation, retractors, forceps, curettes, and bone-coring punches. It also produces non-bioabsorbable spinal bone screws and aneurysm clips, as well as general-purpose surgical scissors.

These devices are regulated under FDA Class I and Class II classifications, with submissions recorded in the FDA’s 510(k) and UDI registries. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does AESCULAP, INC. manufacture?

AESCULAP, INC. specializes in reusable surgical instruments primarily used in orthopaedic and spinal procedures. Their portfolio includes positioning instruments for prosthesis implantation, retractors, forceps, bone curettes, bone-coring punches, and general-purpose surgical scissors. They also produce non-bioabsorbable spinal bone screws and aneurysm clips, which are critical for vascular surgeries.

Where is AESCULAP, INC. based, and what does that mean for its regulatory oversight?

AESCULAP, INC. is based in the United States, meaning its devices fall under FDA jurisdiction. The FDA classifies their products as either Class I (generally low-risk, like general-purpose scissors) or Class II (moderate-risk, such as bone screws or aneurysm clips), requiring compliance with specific regulatory pathways like the 510(k) premarket notification process.

Which regulatory registries list AESCULAP, INC.’s devices, and why does that matter?

AESCULAP, INC.’s devices are recorded in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) process demonstrates that new devices are substantially equivalent to existing ones, while the UDI system ensures traceability and transparency in the supply chain, helping healthcare providers verify device safety and compliance before use.

How are AESCULAP, INC.’s devices classified under FDA regulations, and what does that classification entail?

AESCULAP, INC.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices, like reusable surgical scissors, typically require general controls (e.g., labeling, manufacturing practices) to ensure safety. Class II devices, such as spinal bone screws or aneurysm clips, involve additional performance standards or post-market surveillance to mitigate higher risks, like improper placement or material failure.

AI-generated from registry data and not verified by a human reviewer.

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 20 of 310

Device	Model / Reference	Registries	Class	Status
Aesculap	GK614R	FDA UDI	Class II	Active
Aesculap	BH177US	FDA UDI	Class I	Active
Aesculap	MN226R	FDA UDI	Class II	Active
Aesculap	EA156R	FDA UDI	Class I	Active
Aesculap	OG075R	FDA UDI	Class I	Active
AS univation® XF	NO187Z	FDA UDI	Class II	Active
Aesculap	MG684R	FDA UDI	Class I	Active
Aesculap	NV020T	FDA UDI	Class II	Active
Aesculap	US190	FDA UDI	Class II	Active
Sq.line	FK757NR	FDA UDI	Class I	Active
Ennovate C	SQ338TS	FDA UDI	Class II	Active
Sensation	FM131R	FDA UDI	Class I	Active
Columbus Revision	NQ739R	FDA UDI	Class I	Unknown
Aesculap	FB397R	FDA UDI	Class I	Active
Durogrip	FM388R	FDA UDI	Class I	Active
Sse	SX328T	FDA UDI	Class II	Unknown
Aesculap	EJ766R	FDA UDI	Class II	Unknown
Aesculap	MF322R	FDA UDI	Class I	Active
As	NR401Z	FDA UDI	Class II	Unknown
Aesculap	MF388T	FDA UDI	Class II	Active
Prospace®	SN090P	FDA UDI	Class II	Active
Enduro	NB068K	FDA UDI	Class II	Unknown
Aesculap	MD562	FDA UDI	Class I	Active
Cutfix	5518016	FDA UDI	Class I	Active
Cranioplate	FM926T	FDA UDI	Class II	Unknown
Aesculap	FM452R	FDA UDI	Class I	Active
Aesculap	NQ313	FDA UDI	Class II	Active
Aesculap	MD928	FDA UDI	Class I	Active
Aesculap	NQ310	FDA UDI	Class II	Active
Aesculap	OL406R	EUDAMEDFDA UDI	Class I	Active
Aesculap	GP492R	FDA UDI	Class II	Unknown
Aesculap	PM190R	FDA UDI	Class II	Active
Columbus® CR	NN037K	FDA UDI	Class II	Active
Aesculap	FW744P	FDA UDI	Class I	Active
Aesculap	MD569	FDA UDI	Class I	Active
Cutfix	16600550	FDA UDI	Class I	Active
AS Columbus® REVISION F	NR074Z	FDA UDI	Class II	Active
Aesculap	FW775R	FDA UDI	Class I	Active
Aesculap	OK680R	FDA UDI	Class I	Active
AS Columbus® CR	NN909Z	FDA UDI	Class II	Active
AS Columbus® REVISION	NR241Z	FDA UDI	Class II	Active
Columbus	NE362R	FDA UDI	Class I	Unknown
Enduro	NR892M	FDA UDI	Class II	Unknown
Aesculap	GF862R	FDA UDI	Class II	Active
Aesculap	FT724T	FDA UDI	Class II	Active
Aesculap	FF300R	FDA UDI	Class I	Active
Aesculap	EA106R	FDA UDI	Class I	Active
Aesculap	FF617R	FDA UDI	Class I	Active
Aesculap	BJ061R	FDA UDI	Class I	Active
Aesculap	SW342T	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

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Importers

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Authorities

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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.

AESCULAP, INC. has 44 recall records spanning from November 1, 2007, to January 15, 2026, with statuses including open, classified, and terminated. The reasons cited involve potential mechanical failures, manufacturing defects, incorrect material usage, laser marking errors, and deviations from intended device use, such as misinterpretation of motor signals, corrosion in joints, breakage of components, and improper energy release. Some recalls address labeling inaccuracies, such as incorrect angle markings on implants or size identification errors on surgical guides.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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