Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
A.T.S. 4000TS Tourniquet Systems Recalled by Zimmer Surgical Inc Due to Updated on-device label and 3 pages of an...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer Surgical Inc directly.
Affected Products
A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. .
Quantity: 8,231 devices total
Why Was This Recalled?
Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zimmer Surgical Inc
Zimmer Surgical Inc has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report