Color Cuff 5922044135Recalls & reported problems
Stryker Corporation · Non-Sterile Reusable Tourniquet Cuff Single Bladder, Single Port and Quick Connect Connector · Class 1
All models of Color Cuff (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613154600137), received between Jul 26, 2022 and May 15, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Decrease in Pressure” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Decrease in Pressure2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Burn(s)1
- Tissue Breakdown1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2026Fracture
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY A CRACK WAS OBSERVED ON THE TOURNIQUET CUP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185301 ↗MalfunctionOct 24, 2022Decrease in Pressure; Decrease in Pressure
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 1 EVENT WHICH HAD A MILD INJURY, ILLNESS OR IMPAIRMENT WHICH CAN BE TREATED WITH MINIMAL OR NO INTERVENTION.
Patient problems: Burn(s); Tissue Breakdown
MAUDE report 15663638 ↗MalfunctionJul 26, 2022Decrease in Pressure; Decrease in Pressure
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15107959 ↗
Other TOURNIQUET, PNEUMATIC devices
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- N/AStryker Sustainability Solutions, Inc. · TOURNIQUET, PNEUMATIC1 recall72 reports
- Color Cuff 5921018235Stryker Corporation · TOURNIQUET, PNEUMATIC2 recalls20 reports
- N/AStryker Sustainability Solutions, Inc. · TOURNIQUET, PNEUMATIC1 recall38 reports
- SmartPump 5920011000Stryker Corporation · TOURNIQUET, PNEUMATIC72 reports
- N/AStryker Sustainability Solutions, Inc. · TOURNIQUET, PNEUMATIC1 recall20 reports
- A.T.S.® Personalized Pressure® 60320010100Zimmer Orthopaedic Surgical Products, Inc. · TOURNIQUET, PNEUMATIC1 recall20 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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