Z-1695-2026Class II

Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS...

Name: Z-1695-2026 Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS...
Creator: Olympus Corporation of the Americas
Published: 2026-02-27
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2026-02-27 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU... on 2026-02-27. FDA classified it as Class II and gives the reason as "Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1695-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-27
Posted: 2026-03-30
Recalling firm: OLYMPUS Corporation of the Americas
Product: Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On February 27, 2026 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Examine your inventory and identify any of the affected devices listed in the attachment. 2. Olympus requests that you acknowledge receipt of this letter through our recall web portal. 3. Olympus representatives will begin contacting customers to coordinate the service of affected unit(s). In the meantime, you may continue using your SOLTIVE Laser until the service is completed. Olympus will replace the 24V power supply module at no charge to you. Note: Any issues beyond the replacement of the 24V module in this corrective action will follow the standard SOLTIVE Laser repair process and your service contract, if applicable. 4. If you have further distributed the affected products, please forward this notice to other users who may be impacted.
Quantity in commerce: 32 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.
Product codes and lots: Laser System: TFL-SLS; UDI: 00821925044135; Component Part: TFL-CSLU; UDI: 00821925044593; Serial #: MDUF190114, MDUF220073, MDUF220331, MDUF220353, MDUF220354, MDUF220356, MDUF220411, MDUF220412, MDUF220413, MDUF220414, MDUF220427, MDUF220451, MDUF220453, MDUF220454, MDUF220455, MDUF220456, MDUF230004, MDUF230005, MDUF230006, MDUF230007, MDUF230076, MDUF230140, MDUF230141, MDUF230163, MDUF230164, MDUF230166, MDUF230167, MDUF230234, MDUF230283, MDUF230284, MDUF230331, MDUF230332, MDUF230361, MDUF230362, MDUF230363, MDUF230364, MDUF230365, MDUF230366, MDUF230411, MDUF230412, MDUF230413;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1695-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1694-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-30
Z-1695-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-30

Product code GEX

K242191Class IISOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies America / cleared 2024-08-23

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)