Facility

ASPEN SURGICAL PRODUCTS, INC.

4 recall(s) on record — most severe on record: Class II.

Key facts

4recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002750084
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198
Location	6945 SOUTHBELT DR. S.E. Caledonia, MI, US 49316
Registration status	Active · expires 2026
Parent company	Aspen Surgical Products (owner-operator 10061390)
Brand names	Symmetry Surgical; Bovie Medical; Olsen Medical

Activity by year

Recalls (4)
Inspections (1)

Devices registered here (1)

Electrosurgical, Cutting & Coagulation & Accessories
Product code GEI (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4400

Recalls & enforcement

Class IICompleted2024-06-03
The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.
Class IITerminated2021-07-23
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 p…
Class IITerminated2014-03-20
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.
Class IITerminated2013-07-18
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 b…

FDA inspections (1)

VAI2017-11-08
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ASPEN SURGICAL PRODUCTS, INC. (FEI 3002750084) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002750084-aspen-surgical-products-inc/

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