Z-0748-2024Class II

SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S...

Name: Z-0748-2024 SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S...
Creator: Olympus Corporation of the Americas
Published: 2023-12-01
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-12-01 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS on 2023-12-01. FDA classified it as Class II and gives the reason as "Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0748-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-01
Posted: 2024-01-18
Recalling firm: OLYMPUS Corporation of the Americas
Product: SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On December 1, 2023, the firm issued URGENT MEDICAL DEVICE CORRECTION letters to affected customers. Customers were provided with copies of the labeling addendum to add to remaining inventory. Customers may continue to use the product, but this should be done in accordance with the labeling addendum. If you require additional information, please contact Olympus at (647) 999-3203 or at [email protected].
Quantity in commerce: 82,200 total units (5 per box)
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Europe, Hong Kong, Australia, Japan, Singapore, and Latin America.
Product codes and lots: Models UDI/GTIN TFL-FBX150S 00821925043916 TFL-FBX200S 00821925043930 TFL-FBX365S 00821925043992 TFL-FBX550S 00821925044036 TFL-FBX940S 00821925044074 TFL-FBX150BS 00821925043879 TFL-FBX200BS 00821925043978 All lots affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0748-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0748-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-18

Product code GEX

K183647Class IISOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)Olympus Surgical Technologies America / cleared 2019-08-09

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)