SOLTIVE SuperPulsed Laser Fibers May Have Breached Sterile Pouch Seals
Olympus Corporation recalls 179 SOLTIVE SuperPulsed Laser Fibers due to potentially breached sterile pouch seals that could cause procedure delays or patient infections if not detected before use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving potential for patient infection if the breached sterile seal is not detected before use. No illnesses or injuries have been reported. Per the severity rubric, when no injuries are reported and the hazard is theoretical, the maximum score is 3 (High).
Plain-English summary
Olympus Corporation of the Americas is recalling 179 units of SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS. The affected units have sterile pouch seals that may be breached.
A breached sterile seal may result in minor procedure delays if the breach is detected before use, or patient infections if the breach is not detected prior to use.
The affected units were distributed domestically across 29 U.S. states including Alaska, Arkansas, Arizona, California, Florida, Georgia, Iowa, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, North Carolina, North Dakota, Nebraska, New Jersey, New York, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, and Wisconsin. International distribution occurred to Canada, Latin America, and Europe. Affected units are identified by UDI-DI 00821925043985 and Lot KR262848.
The recalled product
- Product
- SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Laser Fibers
- Affected units
- 179
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 00821925043985 Lot KR262848
Distribution
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