RegWardenFDA facility compliance records
Facility

Aspen Surgical Products, Inc.

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

Activity by year

FDA actions on record by year2013: 1 recalls; 2014: 1 recalls; 2021: 1 recalls; 2024: 1 recalls1’131’14’15’16’17’18’19’201’21’22’231’24’25’26
  • Recalls (4)

Devices registered here (1)

  • Cover, Shoe, Operating-Room
    Product code FXP (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4040

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…

Related

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 3021074643) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3021074643-aspen-surgical-products-inc/

Not open yet

Alerts for Aspen Surgical Products, Inc.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.