N/A (REF 5921-034-235)Recalls & reported problems
Stryker Sustainability Solutions, Inc. · Tourniquet Color Cuff Dual Port, Single Bladder (Purple), Quick Connect · Class 1
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 Color Cuff tourniquet is a disposable pneumatic cuff used to restrict blood flow during surgery. Most of the 82 reports describe air leaks, with cuffs not holding pressure. The reports include 1 injury and no deaths. There is 1 recall, open since March 2023, over cuffs that fail to hold pressure because the fabric tears or an O-ring is pinched or unseated.
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
- 82
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00885825016197), received between Nov 8, 2016 and Jun 10, 2026 — classified as 1 injury, 81 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (76 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
- Mar 1, 2023Open, Classified
Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications.
Z-1315-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash76
- Decrease in Pressure5
- Air Leak1
- Defective Device1
- Noise, Audible1
- Torn Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions72
- Insufficient Information5
- No Consequences Or Impact To Patient4
- Hemorrhage/Blood Loss/Bleeding1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2026Leak/Splash
IT WAS REPORTED A DEFECTIVE CUFF. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 25463740 ↗MalfunctionApr 2, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE TOURNIQUET CUFF WAS LEAKING AND WOULD NOT HOLD PRESSURE. AS REPORTED, IT WAS FOUND TO BE A LEAK IN THE CREASE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS FIFTEEN MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21757277 ↗MalfunctionMar 27, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WOULD NOT HOLD PRESSURE EVEN AFTER CHANGING O-RING. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18987647 ↗MalfunctionOct 30, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS DEFECTIVE AS IT HAD AN AIR LEAK. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18031365 ↗MalfunctionOct 19, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WOULD NOT INFLATE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND THE COMPLAINANT IS NOT AWARE OF ANY EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17969993 ↗MalfunctionSep 28, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE HAD AN AIR LEAK. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17835315 ↗MalfunctionSep 28, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE HAD AN AIR LEAK. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17834510 ↗MalfunctionJun 12, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS NOT HOLDING PRESSURE DURING ORTHOPEDIC SURGERY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17114306 ↗MalfunctionJun 12, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS NOT HOLDING PRESSURE DURING ORTHOPEDIC SURGERY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17114304 ↗MalfunctionJun 12, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS NOT HOLDING PRESSURE DURING ORTHOPEDIC SURGERY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17114263 ↗MalfunctionJun 12, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS NOT HOLDING PRESSURE DURING ORTHOPEDIC SURGERY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17114262 ↗MalfunctionMay 9, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE CUFF WAS NOT WORKING AND NOT INFLATING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16899411 ↗MalfunctionApr 24, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS NOT WORKING - NOT INFLATING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16800214 ↗MalfunctionApr 24, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS NOT WORKING - NOT INFLATING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16800049 ↗MalfunctionApr 24, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS NOT WORKING - NOT INFLATING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16800048 ↗MalfunctionApr 24, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS NOT WORKING - NOT INFLATING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16800038 ↗MalfunctionApr 19, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE LEAKED, WOULD NOT INFLATE, AND WAS REPLACED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16768911 ↗InjuryApr 17, 2023Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure
IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY. THE TOURNIQUET CUFF WOULD NOT HOLD AIR PROPERLY AND THE PATIENT HAD MORE BLEEDING DURING THE PROCEDURE AND MORE CAUTERIZATION WAS NEEDED THAN USUAL DURING THE PROCEDURE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 16755817 ↗MalfunctionApr 13, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WOULD NOT HOLD AIR AND WOULD CONTINUOUSLY TRY TO FILL. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16739479 ↗MalfunctionApr 13, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED, THE DEVICE WAS LEAKING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. AND EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN 30 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16738776 ↗MalfunctionApr 13, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED, THE DEVICE WOULD NOT HOLD AIR AND WOULD CONTINUOUSLY TRY TO FILL. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16738772 ↗MalfunctionApr 13, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WOULD LEAK DURING USE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16732437 ↗MalfunctionApr 13, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WOULD LEAK DURING USE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16732436 ↗MalfunctionApr 13, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WOULD LEAK DURING USE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16732282 ↗MalfunctionApr 5, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DEVICE WAS AUDIBLY LEAKING AIR AND THE DEVICE PUMP WAS SOUNDING AN ALARM. THERE WAS NO PATIENT INJURY REPORTED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME, HOWEVER, NO INFORMATION WAS PROVIDED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16686711 ↗
Other TOURNIQUET, PNEUMATIC devices
- 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
- Color Cuff 5921-034-135NSStryker Corporation · 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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