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Recall Observatory FDA recall evidence

Device product

SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

Z-0718-2024

December 04, 2023

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 93629
Status
Ongoing
Classification
Class II
Quantity
179 units
Official record key
device-enforcement:Z-0718-2024

Official wording

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).

Code information: UDI-DI 00821925043985 Lot KR262848

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).