Z-0109-2024Class II

THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic...

Name: Z-0109-2024 THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic...
Creator: Olympus Corporation of the Americas
Published: 2023-09-12
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-09-12 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and... on 2023-09-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0109-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-12
Posted: 2023-10-12
Recalling firm: OLYMPUS Corporation of the Americas
Product: THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-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
Product code: LFL Instrument, Ultrasonic Surgical
Reason for recall: 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
FDA root cause: Under Investigation by firm
Action: UPDATE: Olympus issued a revised letter for additional lots titled: Correction to letter dated September 13, 2023- Additional Lot numbers on January 11, 2024. Olympus issued Urgent Medical Device Recall Letter on 9/13/23 to Healthcare Professional. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory and identify any THUNDERBEAT models and lots subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. The lot number can be found on the box or pouch. 2. Call your Olympus customer service representative at 1-800-848-9024, option 2, with the quantity, model, and lot number of affected devices. Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of affected product. 3. Access the Olympus recall portal to indicate that you have received this notification: a. Go to https://olympusamerica.com/recall. b. Enter the recall number: 0431 4. If you have distributed these devices outside your facility, please notify your customers of this matter immediately. Your notification to your customers may be enhanced by including a copy of this letter. Olympus requests that you report complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1.
Quantity in commerce: 271 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 4953170409684 Lot Numbers: KR310806 KR310809 KR313734 KR319658 KR326619 KR326628 KR333661 Lots Added January 11, 2024: KR310806 KR310809 KR333661 KR342666

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0109-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0108-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-12
Z-0109-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-12

Product code LFL

K211838UnclassifiedUltrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation / cleared 2021-08-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)