Class 2 Device Recall Expressaire

• Date Initiated by Firm: August 24, 2026
• Date Posted: October 01, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0025-2027
• Recall Event ID: 99676
• Product Classification: Tourniquet, pneumatic - Product Code KCY
• Product: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 1-LINE (CS 12) GRAY Model/Catalog Number: A70107004 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No
• Code Information: Lot Code: Model Number: A70107004 UDI-DI: (01) 00885914035481 All Lots produced from 01SEP2016 to 01MAR2023: R0310STY, R1201STY
• FEI Number: 3004824601
• Recalling Firm/ Manufacturer: ASP Global, LLC.; 7800 Third Flag Pkwy; Austell GA 30168-7657
• For Additional Information Contact: Tracy Weldon; +1-470-6490135
• Manufacturer Reason for Recall: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
• FDA Determined Cause: Under Investigation by firm
• Action: On 08/24/2026, an "URGENT MEDICAL DEVICE RECALL" Letter was emailed to customers informing them that, ASP Global identified a discrepancy between the labeled shelf life and available shelf-life validation data for certain Sterile Disposable Tourniquet Cuff products. While affected products were labeled with a 10-year shelf life, available validation documentation supports a shelf life of 5-years. Customer are instructed to: a) Review Appendix A to identify affected item codes and lot numbers. b) Discontinue use of the affected products. c) Quarantine any remaining impacted inventory to prevent further use. d) Complete and return the enclosed Recall Response Form to confirm receipt and actions to FieldActions@aspglobal.com. e) Dispose remaining inventory in accordance with the local facility s guidelines or notify ASP Global at FieldActions@aspglobal.com for return authorization and disposal assistance. f) If customers have distributed affected products to other facilities or customers, notify those recipients of this recall and provide them with a copy of this notification. For questions regarding this recall, contact: ASP Global Field Actions Team Email: FieldActions@aspglobal.com Phone: (855)-867-2190| Mon Fri, 9:00 AM 5:00 PM EST
• Quantity in Commerce: 396
• Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.