Z-0718-2024Class II

SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

Name: Z-0718-2024 SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Creator: Olympus Corporation of the Americas
Published: 2023-12-04
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-12-04 / Open, Classified / root cause: packaging

FDA source

Olympus Corporation of the Americas began a recall of SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS on 2023-12-04. FDA classified it as Class II and gives the reason as "Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0718-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-04
Posted: 2024-01-12
Recalling firm: OLYMPUS Corporation of the Americas
Product: SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On December 4, 2023, the firm notified affected customers via Urgent Medical Device Removal letters. Customers were instructed to identify and quarantine the affected model/lot. Affected product should not be used. Olympus will issue a credit to customers upon the return of the affected product. If product was distributed outside the customer's facility, the customer should notify those outside facilities immediately. If you require additional information, please contact the company by phone at (647) 999-3203 or by e-mail at [email protected].
Quantity in commerce: 179 units
Distribution: Domestic distribution to the following states: AK AR AZ CA FL GA IA ID IN KS KY LA MA MI NC ND NE NJ NY OR PA SC SD TN TX VA WI International distribution to Canada, Latin America, and Europe.
Product codes and lots: UDI-DI 00821925043985 Lot KR262848

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0718-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0718-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-12

Product code GEX

K221306Class IISOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and AccessoriesGyrus Acmi, Inc. / cleared 2023-01-27

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)