Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hercules 360 Universal Stabilizing Arm Recalled by Terumo Cardiovascular Systems Corporation Due to Terumo Cardiovascular Systems (Terumo CVS) is recalling certain...
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 Terumo Cardiovascular Systems Corporation directly.
Affected Products
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
Quantity: The total number of distributed devices stands at 260
Why Was This Recalled?
Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal Stabilizing Arms because the two pins that hold the sleeve attached to the distal end of the device may come loose, causing the pins and sleeve to separate from the device. While the arm can still function without the pins and sleeve in place, there is potential for the loose components to fall into the surgical site.
Where Was This Sold?
Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees .
About Terumo Cardiovascular Systems Corporation
Terumo Cardiovascular Systems Corporation has 204 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report