Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Marco Shoulder Stabilization Kit Recalled by Aspen Surgical Products, Inc. Due to Affected products were manufactured with materials found to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Aspen Surgical Products, Inc. directly.
Affected Products
Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
Quantity: 4270
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Aspen Surgical Products, Inc.
Aspen Surgical Products, Inc. has 23 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report