Fresh Recalls

FDAClass II · Medical device · Recall Z-0040-2027 · Recalled October 7, 2026

Brand Name recall — ASP Global, LLC.

Agency report date: October 7, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Brand Name
Company / brand
ASP Global
Lot / serial / date codes
Lot Code: Model Number: ASP-564007 UDI-DI: (01) 00840216106727 All Lots produced from 01SEP2016 to 01MAR2023: P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, N0730STY, M0130STY, M0430STY, M0730STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY
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.
Agency product description and boundaries

Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-Line, Red Model/Catalog Number: ASP-564007 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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Brand Name recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-0040-2027
Brand
All ASP Global recalls
Classification
Class II
Units affected
55,050
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Austell, GA, United States
Firm address
7800 Third Flag Pkwy, 30168-7657

Identifying details (verbatim from the notice)

Product codes / lots
Lot Code: Model Number: ASP-564007 UDI-DI: (01) 00840216106727 All Lots produced from 01SEP2016 to 01MAR2023: P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, N0730STY, M0130STY, M0430STY, M0730STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY
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.
Firm notified the public via
Letter
FDA event ID
99676
Recall initiated
August 24, 2026
FDA classified
October 1, 2026
FDA report date
October 7, 2026

Other medical device recalls from around the same time

Verify with the official sources:

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.

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