Device recall: Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm…

Class II FDA enforcement event 95950. Recall start date: 25 Nov 2024. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Olympus Corporation of the Americas started this device recall on 25 Nov 2024. The firm address in the FDA record is in Center Valley, PA. FDA put the recall in Class II. FDA event 95950 has 11 product records. The first FDA enforcement report date is 29 Jan 2025. The record gives the status Ongoing.

FDA enforcement report The 11 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso,…

Recalling firm

Olympus Corporation of the Americas, Center Valley, PA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

11 product records in the event.

FDA event 95950: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0993-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: R5000687 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended…	495,865 units (96,253 US, 399,612 OUS)	Class II	Ongoing	29 Jan 2025
Z-0994-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used…	34,325 units (13267 US, 21058 OUS)	Class II	Ongoing	29 Jan 2025
Z-0995-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424030 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended…	36,712 units (OUS Only)	Class II	Ongoing	29 Jan 2025
Z-0996-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423730 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended…	128,608 units (OUS ONLY)	Class II	Ongoing	29 Jan 2025
Z-0997-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423630 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended…	54,500 units (OUS ONLY)	Class II	Ongoing	29 Jan 2025
Z-0998-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423330 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to…	9,200 units (OUS ONLY)	Class II	Ongoing	29 Jan 2025
Z-0999-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423430 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to…	4,055 units (OUS ONLY)	Class II	Ongoing	29 Jan 2025
Z-1000-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423510 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to…	112 units (OUS ONLY)	Class II	Ongoing	29 Jan 2025
Z-1001-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5423930 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended…	84,570 units (4489 US, 80081 OUS)	Class II	Ongoing	29 Jan 2025
Z-1002-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424110¿ Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended…	11,329 units (OUS ONLY)	Class II	Ongoing	29 Jan 2025
Z-1003-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423810 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended…	27,352 units (OUS ONLY)	Class II	Ongoing	29 Jan 2025

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2024: 970
Share of these events in Class II: 87%
Product records in this event: 11Median of the firm: 1
Events of the firm on the register: 141

Other events of the firm

Other FDA enforcement events of Olympus Corporation of the Americas
Initiated	Product (first record)	Type	Class	Records
18 Aug 2026	POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting &	Device	Class II	1
7 Jul 2026	Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying	Device	Class II	1
16 Jun 2026	Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4	Device	Class II	1
5 Jun 2026	Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designe	Device	Class II	1
5 May 2026	Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.	Device	Class II	4
25 Mar 2026	OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-E	Device	Class II	12
23 Mar 2026	Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.	Device	Class II	4
27 Feb 2026	Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Ca	Device	Class II	2
25 Feb 2026	Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Cata	Device	Class II	7
12 Feb 2026	Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.	Device	Class II	4

Olympus Corporation of the Americas: all 141 events

Official channels

FDA enforcement report Z-0993-2025The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 95950. https://recallregister.com/fda/ii/95950/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso,…
What quantity of product is in FDA event 95950?: The event has 11 product records. The first record gives this quantity: 495,865 units (96,253 US, 399,612 OUS)
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2024 have the same class?: 87% of the 970 device events that started in 2024 are in Class II.