FDA Medical Device Recalls (openFDA)
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 number
- Z-0592-2020
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- 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.
- Status
- Terminated
- Initiated
- 2019-11-06
- Posted
- not on file
- Terminated
- 2021-11-19
- Reason
- There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 16,380 total
- Distribution
- Worldwide distributions - US Nationwide distributions in the states of AL, CD, HI, IA, ID, IN, KS, KY, MA, ME, MI, MN, MT, NC, NE, NH, NJ, NV, NY, OK, OR, PA, SC, SD, TN, VA, WI, WV, and WY. Countries of Argentina, Australia, Canada, and Netherlands.
- Lot, serial or model codes
- GTIN: 37613154599258, Lot Numbers 60180348, 60180373
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KCY
- Firm FEI
- 1811755
- Firm city
- Portage
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28