Stryker Instruments Div. of Stryker Corporation Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.
Brand
Stryker Instruments Div. of Stryker Corporation
Lot Codes / Batch Numbers
GTIN: 37613154599258, Lot Numbers 60180348, 60180373
Products Sold
GTIN: 37613154599258, Lot Numbers 60180348, 60180373
Stryker Instruments Div. of Stryker Corporation is recalling Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Qu due to There is a potential for the cuff to leak air leading to a loss of vascular occlusion.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
Recommended Action
Per FDA guidance
Urgent Medical Device Recall Notification letters dated 11/6/19 were sent to customers. Actions to be taken: 1. Immediately review this Recall Notification and the Business Reply Form. 2. Immediately check all stock areas and/or operating room storage for affected products. Quarantine and discontinue use of any Color Cuff Disposable Tourniquet Cuffs identified in this Notification. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Return the completed BRF via fax (8665212762) or email to kara.spath@stryker.com. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4. If you have further distributed this product, please forward copies of this Notification and the BRF to all affected locations, for each location to complete and return. Even if you have distributed all product to another location, please complete a BRF and indicate each location that received product. 5. If the BRF for your facility indicates that recalled product is currently on hand, a shipping label will be provided which should be used to return recalled product. Upon receipt of the recalled product, a credit will be applied to your account.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026