Aesculap, Inc.
United Statesfrom the FDA registration address FDA FEI 2916714
Part of Aesculap AG
Aesculap, Inc. is a medical device manufacturer, with 4,358 devices listed and 46 FDA recalls as of 13 Nov 2026.
- Devices
- 4,358
- Registrations
- FDA
- FDA recalls
- 4620 ongoing
Registry facts
- Registries
- EUDAMED 3,000
- FDA GUDID 3,000
- Device classes
- FDA Class I 1,620
- FDA Class II 1,380
- FDA recalls
- Sites and related companies
- Identifiers
- FDA FEI 2916714
- DUNS 082594540
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
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.
Catalogue
Search and filter all 4,358 devicesShowing 1-50 of 4,358
Company details
- FDA FEI number
- 2916714
- DUNS number
- 082594540
- Address
- 3773 CORPORATE PKWY., CENTER VALLEY, PA, 18034
- Phone
- +1(800)282-9000
FDA recalls
FDA recall records list 46 recalls initiated by AESCULAP, INC., the earliest on 2007-11-01 and the most recent on 2026-01-15. By recorded status: 20 ongoing and 26 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 2
- 2024 6
- 2025 11
- 2026 1
2026
- 15 Jan 2026 Z-1485-2026 Class II Ongoing There is the potential for the length of the trocar shaft to be too long.
Full distribution text
- 15 Jan 2026 Z-1485-2026 Class II Ongoing There is the potential for the length of the trocar shaft to be too long.
2025
- 24 Sep 2025 Z-0309-2026 Class II Ongoing It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Full distribution text
- 24 Sep 2025 Z-0310-2026 Class II Ongoing It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Full distribution text
- 24 Sep 2025 Z-0311-2026 Class II Ongoing It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
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- 24 Sep 2025 Z-0312-2026 Class II Ongoing It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
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- 18 Aug 2025 Z-0026-2026 Class II Ongoing Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Full distribution text
- 18 Aug 2025 Z-0027-2026 Class II Ongoing Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Full distribution text
- 31 Jan 2025 Z-1308-2025 Class II Ongoing The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
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- 31 Jan 2025 Z-1309-2025 Class II Ongoing The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Full distribution text
- 31 Jan 2025 Z-1310-2025 Class II Ongoing The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Full distribution text
- 24 Sep 2025 Z-0309-2026 Class II Ongoing It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Show the 25 most recent of 46 recalls
2025
- 31 Jan 2025 Z-1311-2025 Class II Ongoing The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Full distribution text
- 31 Jan 2025 Z-1312-2025 Class II Ongoing The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Full distribution text
- 31 Jan 2025 Z-1311-2025 Class II Ongoing The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
2024
- 13 May 2024 Z-2139-2024 Class II Ongoing 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.
- 9 Jan 2024 Z-1243-2024 Class II Ongoing The sterile blister packaging may be damaged, and sterility may be compromised.
- 9 Jan 2024 Z-1244-2024 Class II Ongoing The sterile blister packaging may be damaged, and sterility may be compromised.
- 9 Jan 2024 Z-1245-2024 Class II Ongoing The sterile blister packaging may be damaged, and sterility may be compromised.
- 9 Jan 2024 Z-1246-2024 Class II Ongoing The sterile blister packaging may be damaged, and sterility may be compromised.
- 9 Jan 2024 Z-1247-2024 Class II Ongoing The sterile blister packaging may be damaged, and sterility may be compromised.
2023
- 29 Dec 2023 Z-0866-2024 Class II Ongoing 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.
- 29 Dec 2023 Z-0867-2024 Class II Ongoing 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.
2015
- 30 Nov 2015 Z-1043-2016 Class II 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.
- 17 Nov 2015 Z-0566-2016 Class II 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
- 10 Nov 2015 Z-0422-2016 Class II 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.
- 10 Nov 2015 Z-0423-2016 Class II 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.
- 10 Nov 2015 Z-0424-2016 Class II 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.
Frequently asked questions
How many devices does AESCULAP, INC. have in the registry?
The registry currently lists 4358 devices for AESCULAP, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list AESCULAP, INC.'s devices?
Among its 50 most recently registered devices, AESCULAP, INC. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (47 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do AESCULAP, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for AESCULAP, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for AESCULAP, INC.?
FDA recall records list 46 recalls initiated by AESCULAP, INC., the most recent initiated on 15 Jan 2026. 20 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from AESCULAP, INC. in the registry?
The most recently registered devices listed for AESCULAP, INC. include AESCULAP MG680R, AESCULAP US981SU, AESCULAP US982SU and AESCULAP US983SU.