Color Cuff 5921018135Recalls & reported problems
Stryker Corporation · Disposable 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Stryker single-bladder disposable tourniquet cuff is used to stop bleeding during surgery. The reports mostly describe the cuff failing to hold pressure during a procedure. There are 31 reports, with no deaths and no injuries. Two recalls name this device: one that began in November 2019, over a potential for the cuff to leak air and lose its grip on blood flow, was terminated; a newer open recall from July 2025 involves the cuff flange detaching from the bladder, which can let air leak and cause heavier-than-expected blood loss.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07613154599257), received between Oct 28, 2019 and Jun 11, 2025 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Decrease in Pressure” (31 reports).
2 FDA recall records 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 ↗
- Nov 6, 2019Terminated
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
Z-0592-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Decrease in Pressure31
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient5
- Insufficient Information2
- No Patient Involvement2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2025Decrease 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 22185516 ↗MalfunctionJun 11, 2025Decrease in Pressure; Decrease in Pressure
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22185515 ↗MalfunctionApr 3, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE IS NOT HOLDING PRESSURE DURING A PROCEDURE AT THE USER FACILITY. UPON FOLLOW UP, THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 21762107 ↗MalfunctionMar 18, 2025Decrease 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 21634862 ↗MalfunctionMar 18, 2025Decrease 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 21633995 ↗MalfunctionMar 18, 2025Decrease 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 21632833 ↗MalfunctionMar 18, 2025Decrease 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 21631367 ↗MalfunctionMar 18, 2025Decrease 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 21631297 ↗MalfunctionMar 14, 2025Decrease in Pressure; Decrease in Pressure
MalfunctionFeb 26, 2025Decrease in Pressure; Decrease in Pressure
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21470515 ↗MalfunctionFeb 25, 2025Decrease 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 21462908 ↗MalfunctionFeb 25, 2025Decrease in Pressure; Decrease in Pressure
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21455439 ↗MalfunctionFeb 18, 2025Decrease 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 21399136 ↗MalfunctionFeb 5, 2025Decrease 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 21312327 ↗MalfunctionFeb 4, 2025Decrease 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 21307741 ↗MalfunctionJan 22, 2025Decrease 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 21211389 ↗MalfunctionJan 22, 2025Decrease 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 21208874 ↗MalfunctionJan 22, 2025Decrease 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 21208609 ↗MalfunctionJan 2, 2025Decrease 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 21055091 ↗MalfunctionDec 26, 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 21021494 ↗MalfunctionDec 26, 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 21021492 ↗MalfunctionDec 26, 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 21020939 ↗MalfunctionDec 26, 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 21020938 ↗MalfunctionDec 26, 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 21020937 ↗MalfunctionMay 23, 2024Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE STARTED TO LEAK 24 MINS 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 19383133 ↗
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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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