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RecallWatchMedical Device Safety
Class IIOngoingZ-0045-2027

ASP Global, LLC. recalls Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF

ASP Global, LLC.Austell, GA, United StatesReported Oct 7, 2026 · 6 days ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-Line, Blue Model/Catalog Number: ASP-564012 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
    Model Number
    19 affected lots
    ASP-5640120084021610677201SEP2016P1015STYP1215STYO0815STYO1020STYN0330STY
    +11 moreN0530STYN0730STYM0130STYM0430STYM0730STYM0930STYM1015STYM1101STYM1115STYL0310STYL0325STY

What the firm is doing

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

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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