Home / Recalls / Stryker Sustainability Solutions / Z-0664-2022

Z-0664-2022 Class II Terminated

Recalled by Stryker Sustainability Solutions — Tempe, AZ

FDA device recall Z-0664-2022 was initiated by Stryker Sustainability Solutions on Jan 21, 2022 and is designated Class II. Reason for recall: Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs. The recall status is terminated (terminated Feb 26, 2025). Affected quantity: 40 units.

Recall Details

Product Type: Devices
Report Date: Mar 2, 2022
Initiation Date: Jan 21, 2022
Termination Date: Feb 26, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 40 units

Product Description

REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder

Reason for Recall

Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.

Distribution Pattern

US: KS OK TX OUS: None

Code Information

Lot # 12983349

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0664-2022
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.