Stryker Color Cuff Tourniquet Cuff Recall: Air Leak Risk in Surgery
Stryker recalls disposable tourniquet cuffs that may leak air, causing loss of blood flow during surgery. Affected units have specific model and lot numbers. Consumers should contact Stryker for details.
Use caution until it’s fixed
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
Contact the company
What happened, in plain English
Stryker is recalling disposable tourniquet cuffs that could leak air, which might cause blood flow to stop during surgery. This is serious because it could lead to complications if the cuff fails while in use. Read more at govinfonow.com/recall/66555-stryker-color-cuff-tourniquet-cuff-recall-air-leak-risk-in.
Source Summary by GovInfoNow · govinfonow.com/recall/66555-stryker-color-cuff-tourniquet-cuff-recall-air-leak-risk-in · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0593-2020
Cite this page
“Stryker Color Cuff Tourniquet Cuff Recall: Air Leak Risk in Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66555-stryker-color-cuff-tourniquet-cuff-recall-air-leak-risk-in. Based on FDA recall #Z-0593-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0593-2020%22&limit=1).
Why it’s dangerous
The cuff may leak air during use, which can cause blood flow to stop in the affected limb. This could lead to complications if the cuff fails while in use during surgery.
Who’s affected
Surgical staff and patients using the Color Cuff tourniquet cuffs during procedures. Those with the specific model and lot numbers are most at risk.
How to tell if you have this one
Check for the product name 'Color Cuff Disposable Tourniquet Cuff', 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT (Dual Port) Quick Connect. Lot numbers 60180374 or 60181194 are affected.
- Brand
Stryker- Product
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide distributions - US Nationwide distributions in the states of AL, CD, HI, IA, ID, IN, KS, KY, MA, ME, MI, MN, MT, NC, NE, NH, NJ, NV, NY, OK, OR, PA, SC, SD, TN, VA, WI, WV, and WY. Countries of Argentina, Australia, Canada, and Netherlands.
| Recall number | Product, codes & lots |
|---|---|
| Z-0592-2020 | Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.; GTIN: 37613154599258, Lot Numbers 60180348, 60180373 |
| Z-0593-2020 | Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.; GTIN: 37613154599296, Lot Numbers 60180374, 60181194 |
What to do — step by step
Check Product Details
Look for the product name, model, and lot numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 28 states.
FDA distribution: “Worldwide distributions - US Nationwide distributions in the states of AL, CD, HI, IA, ID, IN, KS, KY, MA, ME, MI, MN, MT, NC, NE, NH, NJ, NV, NY, OK, OR, PA, SC, SD, TN, VA, WI, WV, and WY. Countries of Argentina, Australia, Canada, and…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Hawaii, Idaho, Indiana, Iowa, Kansas, Kentucky, Maine, Massachusetts, Michigan, Minnesota, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Virginia, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0593-2020 (November 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0593-2020 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.