Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Jessie Sterile Arm Suspension 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
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Quantity: 1429
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