Facility

ASO LLC

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

Key facts

7recalls · worst Class II

—inspections in our data

—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)	1038758
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	300 SARASOTA CENTER BLVD. SARASOTA, FL, US 34240
Registration status	Active · expires 2026
Parent company	ASO LLC (owner-operator 1038758)

Activity by year

Recalls (7)

Devices registered here (1)

Splint, Hand, And Components
Product code ILH (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.3475

Recalls & enforcement

Class IIOngoing2023-03-23
The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling.
Class IIOngoing2022-06-22
The product falls apart during handling after removal from its primary packaging.
Class IITerminated2022-03-02
Kits contained recalled acetaminophen.
Class IIOngoing2018-10-16
Potential that gauze pads may not be fully sterilized
Class IITerminated2015-06-10
Contain 0.1% Benzalkonium Chloride in the 5/8 bandages inside the assortment which is not listed as an active ingredient in the product label.
Class IITerminated2013-08-21
No antibacterial bandages were packed in boxes labeled as antibacterial.
Class IITerminated2013-07-26
This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.

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. “ASO LLC (FEI 1038758) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1038758-aso-llc/

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