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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

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 (1897)

Page 1 of 38

Device	Model / Reference	Registries	Class	Status
Symmetry ®	23-0510	EUDAMED	Class I	Active
Symmetry ®	80-1520-EU	EUDAMED	Class I	Active
Symmetry ®	23-1053	EUDAMED	Class I	Active
Symmetry ®	19-4063	EUDAMED	Class IIa	Active
Symmetry ®	29-6914	EUDAMED	Class I	Active
Symmetry ®	47-4001	EUDAMED	Class I	Active
Symmetry ®	53-1676	EUDAMED	Class I	Active
Symmetry ®	60-1856	EUDAMED	Class I	Active
Symmetry ®	23-7504E	EUDAMED	Class I	Active
Symmetry ®	50-2608-EU	EUDAMED	Class I	Active
Symmetry ®	80-1524-EU	EUDAMED	Class I	Active
Symmetry ®	29-5909	EUDAMED	Class I	Active
Symmetry ®	80-1907-EU	EUDAMED	Class I	Active
Symmetry ®	53-1676RC	EUDAMED	Class I	Active
Symmetry ®	29-6909	EUDAMED	Class I	Active
Symmetry ®	29-6911	EUDAMED	Class I	Active
Symmetry ®	23-0716	EUDAMED	Class I	Active
Symmetry ®	80-1908-EU	EUDAMED	Class I	Active
Symmetry ®	53-1674	EUDAMED	Class I	Active
Symmetry ®	52-7050	EUDAMED	Class I	Active
Symmetry ®	53-1674RC	EUDAMED	Class I	Active
Symmetry ®	55-4930	EUDAMED	Class IIa	Active
Symmetry ®	62-1311	EUDAMED	Class I	Active
Symmetry ®	62-1309	EUDAMED	Class I	Active
Symmetry ®	80-1804-EU	EUDAMED	Class I	Active
Symmetry ®	80-1521-EU	EUDAMED	Class I	Active
Symmetry ®	60-1405I	EUDAMED	Class I	Active
Symmetry ®	29-6654	EUDAMED	Class I	Active
Symmetry ®	23-0514	EUDAMED	Class I	Active
Symmetry ®	24-3204	EUDAMED	Class I	Active
Symmetry ®	940-4728	EUDAMED	Class I	Active
Symmetry ®	80-2015-EU	EUDAMED	Class I	Active
Symmetry ®	80-1525-EU	EUDAMED	Class I	Active
Symmetry ®	32-600L	EUDAMED	Class I	Active
Symmetry ®	80-1522-EU	EUDAMED	Class I	Active
Symmetry ®	57-1250	EUDAMED	Class I	Active
Symmetry ®	46-3015	EUDAMED	Class I	Active
Symmetry ®	60-1833	EUDAMED	Class I	Active
Symmetry ®	37-4006	EUDAMED	Class IIa	Active
Symmetry ®	29-4862A	EUDAMED	Class I	Active
Symmetry ®	55-1027	EUDAMED	Class I	Active
Symmetry ®	29-5911	EUDAMED	Class I	Active
Symmetry ®	23-0713	EUDAMED	Class I	Active
Symmetry ®	60-1814	EUDAMED	Class I	Active
Symmetry ®	29-282	EUDAMED	Class IIa	Active
Symmetry ®	52-6575	EUDAMED	Class I	Active
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

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.

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.