---
title: "SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS — FDA record Z-0718-2024 | Is It on Recall"
description: "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)"
url: https://isitonrecall.com/recall/fda-device-z-0718-2024-soltive-superpulsed-laser-fibers-model-no-tfl-fbx200bs/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS — FDA record Z-0718-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 4, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
- **Reason**: 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).
- **Classification**: Class II
- **Recalling firm**: Olympus Corporation of the Americas
- **Quantity**: 179 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0718-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0718-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI 00821925043985 Lot KR262848 |

Match all identifying details in the current notice. A brand name alone is not enough.

## 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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Alaska](https://isitonrecall.com/state/alaska/)
- [Arkansas](https://isitonrecall.com/state/arkansas/)
- [Arizona](https://isitonrecall.com/state/arizona/)
- [California](https://isitonrecall.com/state/california/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Iowa](https://isitonrecall.com/state/iowa/)
- [Idaho](https://isitonrecall.com/state/idaho/)
- [Kansas](https://isitonrecall.com/state/kansas/)
- [Kentucky](https://isitonrecall.com/state/kentucky/)
- [Louisiana](https://isitonrecall.com/state/louisiana/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [North Dakota](https://isitonrecall.com/state/north-dakota/)
- [Nebraska](https://isitonrecall.com/state/nebraska/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)
- [South Dakota](https://isitonrecall.com/state/south-dakota/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Virginia](https://isitonrecall.com/state/virginia/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)

## Dates in the source

- **Report date**: Jan 24, 2024
- **Recall initiation date**: Dec 4, 2023
- **Center classification date**: Jan 12, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0718-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Olympus Corporation of the Americas records](https://isitonrecall.com/brand/olympus-corporation-of-the-americas/)