Use caution Medical device recall · FDA · Published March 1, 2023

Stryker Color Cuff Tourniquet Cuffs Risk of Pressure Loss Due to Fabric Tearing

Stryker recalls specific Color Cuff tourniquet cuffs that may tear or have faulty O-rings, causing pressure loss and potential bleeding during medical procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1315-2023Medical device Stryker ›

Use caution until it’s fixed

Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications.

Take action

Contact the company

Recalling firmStryker Sustainability Solutions1810 W Drake Dr · Tempe, AZ 85283-4327

✎ GovInfoNow plain-language explainer

Stryker is recalling certain Color Cuff tourniquet cuffs that can tear or have faulty O-rings, leading to pressure loss and possible bleeding during medical procedures. This affects specific sizes and colors sold in the U.S. and Canada. Read more at govinfonow.com/recall/58813-stryker-color-cuff-tourniquet-cuffs-risk-of-pressure-loss-due.

Source Summary by GovInfoNow · govinfonow.com/recall/58813-stryker-color-cuff-tourniquet-cuffs-risk-of-pressure-loss-due · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1315-2023

Cite this page

“Stryker Color Cuff Tourniquet Cuffs Risk of Pressure Loss Due to Fabric Tearing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58813-stryker-color-cuff-tourniquet-cuffs-risk-of-pressure-loss-due. Based on FDA recall #Z-1315-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1315-2023%22&limit=1).

The FDA announced on March 1, 2023, that Stryker Sustainability Solutions is recalling Color Cuff tourniquet cuffs due to a risk of pressure loss. The hazard may lead to operative site blood loss or hemorrhage. Owners should contact the company for a refund.

How to tell if you have it

Brand: Stryker
Product: Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135
Product: Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235
Product: Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-135
Product: Color Cuff Dual Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-235
Product: Color Cuff Single Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-135
Product: Color Cuff Dual Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-235
Units affected: 127,894

The hazard

The recall cites an increased incidence of disposable tourniquet cuffs failing to achieve or hold desired pressure. This failure can result from cuff fabric tearing or a pinched or unseated O-ring at the connection points. Such failures may lead to loss of vascular occlusion, operative site blood loss, hemorrhage, or other complications.

Context

GovInfoNow's records show Stryker Sustainability Solutions has 21 other recalls on record since December 1, 2017. Other recent recalls of similar products include Hamilton Medical IntelliCuff Recall (May 22, 2026), Bard Peripheral Vascular Recall (December 12, 2025), and Zimmer Sterile Tourniquet Hoses recall (June 9, 2026).

How to tell if you have this one

Check for the following: Royal Blue or Purple color, sizes 18, 30, or 34, with the reference numbers listed in the recall notice. The product was sold in the U.S. and Canada.

Brand
Stryker
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the reference number and color to confirm if your cuff is recalled.
Contact Stryker
Reach out to Stryker for guidance on the next steps if your cuff is affected.

Where it went and when

Where it was distributed

Distributed in 49 states and D.C..

FDA distribution: “US: WI, MD, NY, PA, WA, CO, GA, FL, OH, NC, TX, NJ, OR, MT, CA, RI, SC, NE, MI, LA, OK, SD, AL, VA, MS, WV, AZ, KY, IL, AR, ME, ND, MO, KS, HI, NH, AK, TN, IA, MN, IN, NV, MA, ID, DE, NM, WY, DC, VT, CT” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 35 days after the firm started it.

Mar 1, 2023Firm started the recall
Mar 30, 2023FDA classified it Class II
Apr 5, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/58813-stryker-color-cuff-tourniquet-cuffs-risk-of-pressure-loss-due">Stryker Color Cuff Tourniquet Cuffs Risk of Pressure Loss Due to Fabric Tearing (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1315-2023 (March 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1315-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.