Z-2505-2024Class II

Soltive Pro SuperPulsed Laser System, Model TFL-SLS

Name: Z-2505-2024 Soltive Pro SuperPulsed Laser System, Model TFL-SLS
Creator: Olympus Corporation of the Americas
Published: 2024-05-31
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-05-31 / Open, Classified / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Soltive Pro SuperPulsed Laser System, Model TFL-SLS on 2024-05-31. FDA classified it as Class II and gives the reason as "Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2505-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-31
Posted: 2024-08-05
Recalling firm: OLYMPUS Corporation of the Americas
Product: Soltive Pro SuperPulsed Laser System, Model TFL-SLS
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Root cause tag: design
FDA root cause: Device Design
Action: On 06/28/2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of these products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Inspect your inventory and identify any devices with the model names specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification and the Soltive Laser System Instructions for Use, including instructions related to connecting the wireless footswitch. 4. Olympus requests that you acknowledge receipt of this letter. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall b. Enter the recall number "0448 c. Complete the form as instructed and include your account ID number. d. Indicate in the comments if your facility does not have a wired footswitch. Olympus Customer Service will contact you to make arrangements for a wired footswitch. 5. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you report any complaints, including failure of the wireless footswitch pairing with the Soltive Laser System, or any associated injuries to the Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 from Monday through Friday or by e-mail [email protected].
Quantity in commerce: 253 Units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.
Product codes and lots: Model: TFL-SLS; UDI-DI: 00821925044135; Serial Numbers: All Serial Numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2505-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2504-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-05
Z-2505-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-05
Z-2506-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-05

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)