CLASS II ONGOING Device recall · Reported 24 Jan 2024 · FDA Enforcement Report

Soltive SuperPulsed Laser Fibers recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling Soltive SuperPulsed Laser Fibers, distributed in 24 states. The recall was initiated on 4 Dec 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 00821925043985 Lot KR262848

Quantity recalled179 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0718-2024
FDA event ID: 93629
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 4 Dec 2023
FDA classified: 12 Jan 2024
Reported: 24 Jan 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

4 Dec 2023	Recall initiated by company
12 Jan 2024	Classified by FDA	+39 days
24 Jan 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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).

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

Where it was distributed

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.

Alaska Arkansas Arizona California Florida Georgia Iowa Kansas Kentucky Louisiana Massachusetts Michigan North Carolina North Dakota Nebraska New Jersey New York Pennsylvania South Carolina South Dakota

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI 00821925043985 Lot KR262848

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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