Color Cuff 5921024235Recalls & reported problems
Stryker Corporation · Disposable Tourniquet Cuff Single Bladder, Dual Port and Quick Connect Connector · Class 1
All models of Color Cuff (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613154599370), received between May 22, 2024 and Dec 11, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Decrease in Pressure” (5 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jul 2, 2025Open, Classified
Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.
Z-2277-2025 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Decrease in Pressure5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2024Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE IS NOT HOLDING PRESSURE DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20905740 ↗MalfunctionOct 17, 2024Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE SEAL AT THE BASE OF THE TOURNIQUET WHERE THE TUBING AND TOURNIQUET MEET BROKE WHEN THE TOURNIQUET WAS COMING UP TO PRESSURE AND IT WOULD NOT HOLD AIR PRESSURE EFFECTIVELY DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20470779 ↗MalfunctionAug 30, 2024Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE TOURNIQUET IS LEAKING AIR DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20106988 ↗MalfunctionMay 23, 2024Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE WAS USED AND THEN 2 HOURS IN IT STARTED LEAKING DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19382758 ↗MalfunctionMay 22, 2024Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE INITIALLY WORKED AS INTENDED. AFTER A WHILE, THE PUMP WILL ALARM "CUFF LEAK" DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19375890 ↗
Other TOURNIQUET, PNEUMATIC devices
- N/AStryker Sustainability Solutions, Inc. · TOURNIQUET, PNEUMATIC1 recall82 reports
- Color Cuff 5921018135Stryker Corporation · TOURNIQUET, PNEUMATIC2 recalls31 reports
- 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 · each recall links to the FDA recall notice
- 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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