Reported Mar 2, 2022 · Terminated

REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder

Stryker Sustainability Solutions

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Sustainability Solutions · 1810 W Drake Dr · Tempe, AZ · 85283-4327

Is this the product you have?

  • REF5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Lot codes and dates
  • Lot # 12983349
Amount recalled
40 units

Where it was sold

Why it was recalled

Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 26, 2025 · Data as of Sep 19, 5:27 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.