Z-0716-2024Class II

Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365...

Name: Z-0716-2024 Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365...
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: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940 on 2023-12-04. FDA classified it as Class II and gives the reason as "The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a...". 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-0716-2024
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 System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: An URGENT: MEDICAL DEVICE REMOVAL notification letter dated 12/4/23 was sent to customers. Actions to be taken by the end user: Our records indicate that your facility has received one or more affected units. Olympus requests you to take the following actions: 1. Examine your inventory and quarantine any devices with the lot number specified above. 2. Please contact Olympus customer service representative at 1-800-848-9024, option 2, with the quantity and model of affected devices. Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of affected product. 3. 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 "0435 c. Complete the form as instructed. 4. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. Olympus requests you to report any complaints, including product labeling issues, to our 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 in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at [email protected].
Quantity in commerce: 3001 units
Distribution: US Nationwide. Global Distribution
Product codes and lots: Lot Number: All units sold prior to 2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0716-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0716-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-12
Z-0717-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-12

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)