Reported Oct 18, 2023 · Ongoing
THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
THUNDERBEAT5MM45CM
- Front-actuated Grip Type S ModelTB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed
- Lot codes and dates
- UDI-DI4953170409684
- Lot NumbersKR310806 KR310809 KR313734 KR319658 KR326619 KR326628 KR333661 Lots Added January 11, 2024: KR310806 KR310809 KR333661 KR342666
- Amount recalled
- 271 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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