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Brand Name: ASP Global recallZ-0042-2027 · ASP Global, LLC. · initiated Aug 24, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ASP Global, LLC. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company 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 [email protected]. e) Dispose remaining inventory in accordance with the local facility s guidelines or notify ASP Global at [email protected] 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: [email protected] Phone: (855)-867-2190| Mon Fri, 9:00 AM 5:00 PM EST

Recall details

Recall number
Z-0042-2027
Status
Open, Classified
Initiated by the company
Aug 24, 2026
Posted by the FDA
Oct 1, 2026
Recalling firm
ASP Global, LLC.
Quantity
20760
Product code
KCY
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.

Product description

Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-Line, Yellow Model/Catalog Number: ASP-564009 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 (models, lots, serial numbers)

Lot Code: Model Number: ASP-564009 UDI-DI: (01) 00840216106741 All Lots produced from 01SEP2016 to 01MAR2023: P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 99676).

Sources and updates

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