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Aspen Surgical Products, Inc.

United States·US-MF-000008255

Last updated September 17, 2026

About

Discover how Aspen Surgical is enhancing perioperative experiences worldwide. Explore our comprehensive catalog of perioperative solutions including surgical instruments tailored for acute care facilities, ambulatory surgery centers, physician offices, and more. Stay informed with the latest industry trends and news.

From the manufacturer's own website. Source

What Aspen Surgical Products, Inc. makes

Aspen Surgical Products, Inc. manufactures single-use and reusable surgical accessories, including light source adaptors, suturing needles, surgical instrument guards, track identification tape, hand-held retractors, skin marking pens, manual scalpel blades, and surgical vessel loops—all branded under Symmetry®.

The company’s devices are classified as Class I or Class II/IIa under global regulations and are listed in the EU’s EUDAMED database and the FDA’s UDI system. The manufacturer 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 Aspen Surgical Products, Inc. manufacture?

Aspen Surgical Products, Inc. specializes in surgical accessories, including single-use items like suturing needles, surgical instrument guards, skin marking pens, manual scalpel blades, and surgical vessel loops. They also produce reusable devices such as hand-held surgical retractors and light source adaptors. These products are designed to support perioperative procedures in various healthcare settings, including hospitals, ambulatory surgery centers, and physician offices.

Where is Aspen Surgical Products, Inc. based, and how does that affect its regulatory standing?

Aspen Surgical Products, Inc. is headquartered in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations, including classification under the FDA’s device classification system (Class I, Class II, or Class IIa). The company’s products are also listed in the FDA’s Unique Device Identification (UDI) system, ensuring traceability and compliance with U.S. and EU regulatory requirements, as evidenced by their inclusion in the EU’s EUDAMED database.

Which regulatory databases list Aspen Surgical Products, Inc.’s devices, and why is this important?

Aspen Surgical Products, Inc.’s devices are listed in two key regulatory databases: the EU’s EUDAMED system and the FDA’s UDI system. Listing in these databases is important because it ensures transparency, traceability, and compliance with global regulatory standards. EUDAMED helps healthcare professionals and authorities verify device details in the European market, while the FDA’s UDI system provides a standardized way to track devices in the U.S., reducing errors and improving patient safety.

How are Aspen Surgical Products, Inc.’s devices classified under global regulations?

Aspen Surgical Products, Inc.’s devices are classified as either Class I, Class II, or Class IIa under global regulatory frameworks. Class I devices are generally considered low-risk, such as some single-use accessories, while Class II and Class IIa devices involve higher levels of risk and require additional regulatory scrutiny, such as surgical retractors or specialized adaptors. The classification determines the regulatory pathway and compliance requirements for each device type.

Are Aspen Surgical Products, Inc.’s devices available in multiple markets, and how does this affect their regulatory status?

Yes, Aspen Surgical Products, Inc.’s devices are designed for global use, as evidenced by their inclusion in both the FDA’s UDI system and the EU’s EUDAMED database. This dual listing reflects compliance with both U.S. and EU regulatory standards, ensuring the devices meet the necessary requirements for market authorization in these regions. Each device’s classification (Class I, II, or IIa) dictates the specific regulatory pathways and documentation needed for authorization in different markets.

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

Information

Country: United States
Address: 6945 Southbelt Dr SE , Caledonia, MI, United States
Website: aspensurgical.com
LinkedIn: linkedin.com/company/aspen-surgical
Facebook: —
Email: [email protected]
Phone: 888-364-7004
PRRC Contact: Kerry Turner
EUDAMED SRN: US-MF-000008255
FDA FEI Number: 3002750084
DUNS Number: —

Catalogue (1901)

Page 2 of 39

Device	Model / Reference	Registries	Class	Status
Symmetry ®	29-5910	EUDAMED	Class I	Active
Symmetry ®	80-1722-EU	EUDAMED	Class I	Active
Symmetry ®	80-1744-EU	EUDAMED	Class I	Active
Symmetry ®	80-1720-EU	EUDAMED	Class I	Active
Symmetry ®	23-0516	EUDAMED	Class I	Active
Symmetry ®	03-5687	EUDAMED	Class I	Active
Symmetry ®	04-3318E	EUDAMED	Class I	Active
Symmetry ®	55-1026	EUDAMED	Class I	Active
Symmetry ®	80-1693-EU	EUDAMED	Class I	Active
Symmetry ®	24-4591	EUDAMED	Class I	Active
Symmetry ®	31-3027	EUDAMED	Class I	Active
Symmetry ®	23-7225E	EUDAMED	Class I	Active
Symmetry ®	30-1204-EU	EUDAMED	Class I	Active
Symmetry ®	80-1523-EU	EUDAMED	Class I	Active
Symmetry ®	71-3800	EUDAMED	Class I	Active
Symmetry ®	29-6917	EUDAMED	Class I	Active
Symmetry ®	80-1803-EU	EUDAMED	Class I	Active
Symmetry ®	52-2727E	EUDAMED	Class I	Active
Symmetry ®	53-4006-EU	EUDAMED	Class I	Active
Symmetry ®	53-1663R	EUDAMED	Class I	Active
Symmetry ®	31-3124	EUDAMED	Class I	Active
Symmetry ®	80-1802-EU	EUDAMED	Class I	Active
Symmetry ®	04-7130	EUDAMED	Class I	Active
Symmetry ®	60-1404I	EUDAMED	Class I	Active
Symmetry ®	29-5901	EUDAMED	Class I	Active
Symmetry ®	24-4560	EUDAMED	Class I	Active
Symmetry ®	80-2010S	EUDAMED	Class I	Active
Symmetry ®	53-1675	EUDAMED	Class I	Active
Symmetry ®	29-6916	EUDAMED	Class I	Active
Symmetry ®	54-1015-EU	EUDAMED	Class I	Active
Symmetry ®	67-2135E	EUDAMED	Class I	Active
Symmetry ®	29-6910	EUDAMED	Class I	Active
Symmetry ®	80-1700-EU	EUDAMED	Class I	Active
Symmetry ®	80-1692-EU	EUDAMED	Class I	Active
Symmetry ®	62-1312	EUDAMED	Class I	Active
Symmetry ®	24-3500	EUDAMED	Class I	Active
Symmetry ®	29-6655	EUDAMED	Class I	Active
Symmetry ®	24-4018B	EUDAMED	Class I	Active
Symmetry ®	62-1310	EUDAMED	Class I	Active
Symmetry ®	29-4861A	EUDAMED	Class I	Active
Symmetry ®	29-300	EUDAMED	Class IIa	Active
Symmetry ®	55-7555	EUDAMED	Class IIa	Active
Oxboro ™ Specialty Tip Protectors	096013BNS	FDA UDI	Class I	Active
Sterion®Clamp Cover Fabric	061012PBX	FDA UDI	Class I	Unknown
ColorTrack® Identification Sheet Tape	155051EEA	FDA UDI	Class I	Active
Sterion®Clamp Cover Fabric	072002PBX	FDA UDI	Class I	Unknown
Sterion®Clamp Cover Fabric	071002BBG	FDA UDI	Class I	Unknown
Aspen® Rigid Light Handle Adapter	LT-9810X	FDA UDI	Class II	Active
Sterion® Skin Closure	751047PCS	FDA UDI	Class I	Unknown
Oxboro ™ Osteotome Tip Protectors	094015BBG	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (33)

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

Aspen Surgical Products, Inc. has 33 recall records initiated between April 30, 2003, and July 23, 2021, all of which are recorded as terminated. The reasons cited include bioburden levels exceeding sterilization validation limits, potential sterile barrier compromises, missing adaptors in packaging, incorrect expiration dates on individual packages, confirmed sterility issues following FDA sampling, incomplete sterile package seals, and fragments from pads potentially disengaging and adhering to surgical instruments.

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
Jul 23, 2021	Z-2388-2021	—	terminated	Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
Jul 23, 2021	Z-2389-2021	—	terminated	Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
Jul 23, 2021	Z-2390-2021	—	terminated	Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
Mar 20, 2014	Z-1427-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1420-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1425-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1429-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1435-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1419-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1426-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1433-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1430-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1431-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1424-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1428-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1434-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1418-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1422-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1417-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1423-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1421-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Mar 20, 2014	Z-1432-2014	—	terminated	The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Jul 18, 2013	Z-1988-2013	—	terminated	Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling indicated the product may not be sterile. Using the recalled product could lead to infection which may require further treatment including the use of antibiotics. There have been no reports of injuries or illnesses as of 7/18/2013.
Dec 23, 2010	Z-1340-2011	—	terminated	Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
Dec 23, 2010	Z-1339-2011	—	terminated	Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
Dec 23, 2010	Z-1338-2011	—	terminated	Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
Dec 23, 2010	Z-1337-2011	—	terminated	Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
Dec 23, 2010	Z-1335-2011	—	terminated	Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
Dec 23, 2010	Z-1336-2011	—	terminated	Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
Apr 13, 2009	Z-1638-2009	—	terminated	An adaptor, which may be required when connecting the drain to an external device, was not included in the package.
Apr 13, 2009	Z-1639-2009	—	terminated	An adaptor, which may be required when connecting the drain to an external device, was not included in the package.
May 15, 2005	Z-0897-05	—	terminated	An improper expiration date was placed on the individual packages, although the dispenser box and carton contained the correct expiration date.
Apr 30, 2003	Z-0828-03	—	terminated	Sterility compromised - incomplete sterile package seal.