Z-1296-2022Class II

SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber...

Name: Z-1296-2022 SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber...
Creator: Olympus Corporation of the Americas
Published: 2022-05-26
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2022-05-26 / Terminated / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) - 200 Micron... on 2022-05-26. FDA classified it as Class II and gives the reason as "Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1296-2022
Classification: Class II
Status: Terminated
Initiated: 2022-05-26
Posted: 2022-06-28
Terminated: 2025-02-05
Recalling firm: OLYMPUS Corporation of the Americas
Product: SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX200BS (Carton) - 200 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX550S (Carton) - 550 Micron Single Use Fiber Model # Labeled TFL-FBX200S (Carton) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX365S (Pouch) - 200 Micron Single Use Fiber
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Firm notified customers by letter on May 26, 2022. Customers were instructed to return on hand inventory to Olympus for credit.
Quantity in commerce: 190 cartons (950 pieces total)
Distribution: Nationwide distribution in the US. Foreign distribution worldwide.
Product codes and lots: UDI-DI Lot Model# Labeled 00821925043923 KR149856 TFL-FBX150BS (Carton) 00821925043923 KR149856 TFL-FBX200S (Pouch) 00821925043985 KR195775 TFL-FBX200BS (Carton) 00821925044043 KR197789 TFL-FBX550S (Carton) 00821925043930 KR206254 TFL-FBX200S (Carton) 00821925043930 KR206254 TFL-FBX365S (Pouch)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1296-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1296-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-06	2022-06-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)