Z-1382-2026Class II

Olympus Thunderbeat 5 mm, 10 cm, Inline Grip

Name: Z-1382-2026 Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
Creator: Olympus Corporation of the Americas
Published: 2025-10-22
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2025-10-22 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of Olympus Thunderbeat 5 mm, 10 cm, Inline Grip on 2025-10-22. FDA classified it as Class II and gives the reason as "Firm is initiating a removal due to continued reports of adverse events". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1382-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-22
Posted: 2026-02-17
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
Product code: LFL Instrument, Ultrasonic Surgical
Reason for recall: Firm is initiating a removal due to continued reports of adverse events.
FDA root cause: Under Investigation by firm
Action: An URGENT MEDICAL DEVICE PRODUCT REMOVAL notification was mailed to consignees on 12/22/25. The notification instructs consignees to examine inventory for affected devices, immediately cease use and quarantine devices, and contact Customer Service at 1-800-848-9024 (option 2) to obtain a Return Materials Authorization. Credit will be issued to consignees upon return of devices. If product has been further distributed, consignees are to forward the provided notification. Consginees with any questions can contact Cynthia Ow at [email protected] or by phone at 674-999-3203.
Quantity in commerce: 1,538 units
Distribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
Product codes and lots: Model No. TB-0510IC; UDI: 04953170308734; All Units.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1382-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1371-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-17
Z-1372-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-17
Z-1373-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-17
Z-1374-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-17
Z-1375-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-17
Z-1376-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-17
Z-1377-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-17
Z-1378-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-17
Z-1379-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-17
Z-1380-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-17
Z-1381-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-17
Z-1382-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-17

Product code LFL

K111202Class IISurgical Tissue Management SystemOlympus Medical Systems Corp. / cleared 2012-01-20

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)