Color Cuff 5921218235Recalls & 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
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613154599752), received between Nov 14, 2018 and Jan 21, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Decrease in Pressure” (3 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 Pressure3
- Device Contaminated During Manufacture or Shipping1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200861 ↗MalfunctionMar 7, 2023Decrease in Pressure; Decrease in Pressure
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16500409 ↗MalfunctionMay 1, 2019Inflation Problem
TOURNIQUET WOULD NOT INFLATE. CHANGED MACHINE AND TUBING. SURGEON USED A HEMACLEAR TOURNIQUET INSTEAD. USED A SECOND STRYKER TOURNIQUET WITH SAME LOT NUMBER, AFTER TESTING IT, WORKED FINE FOR SECOND PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8568660 ↗MalfunctionApr 24, 2019Decrease in Pressure; Decrease in Pressure
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE DECREASED IN PRESSURE. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8545840 ↗MalfunctionNov 14, 2018Decrease in Pressure; Decrease in Pressure
THE USER FACILITY REPORTED THAT THE DEVICE IS LEAKING. THERE WAS NO PATIENT IMPACT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8071651 ↗
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
- 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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