Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TB-0545PC: THUNDERBEAT 5 mm Recalled by Olympus America Inc. Due to Complaints of damage to various models of Thunderbeat...
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 Olympus America Inc. directly.
Affected Products
TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
Quantity: 8709
Why Was This Recalled?
Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures, including cracking, breaking, or deformation of the components of the probe tip or jaw.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Olympus America Inc.
Olympus America Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report