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N/A (REF 5921-024-235)Recalls & reported problems

Stryker Sustainability Solutions, Inc. · Tourniquet Color Cuff Dual Port, Single Bladder (Yellow), Quick Connect · Class 1

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885825016111), received between Mar 28, 2023 and Mar 28, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Mar 12, 2026Open, Classified

    Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.

    Z-1804-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • Leak/Splash1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 28, 2023Leak/Splash; Leak/Splash

    TOURNIQUET CUFF LEAKED DURING THE CASE. THERE WAS A SMALL INCREASE IN BLOOD LOSS THAN NORMALLY EXPECTED. THE PATIENT IS OKAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16632160 ↗

Other TOURNIQUET, PNEUMATIC devices

All TOURNIQUET, PNEUMATIC devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.