FDA Recalls Olympus Sterile Optical Laser Fibers for Potential Sterility Compromise
Quanta System is recalling Olympus Sterile Optical Laser Fibers nationwide due to potentially compromised sterility. Approximately 26,925 units distributed through six U.S. distributors are affected.
What this means for you
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 medical device recall involving potentially compromised sterility. Although no illnesses or injuries have been reported, the compromise of sterility in medical devices constitutes a significant risk of harm if the products are used.
Plain-English summary
Quanta System, S.p.A. is recalling Olympus Sterile Optical Laser Fiber products (single use and reusable models) because product sterility is potentially compromised. The FDA classified this as a Class II recall.
The recalled products include multiple part numbers with specific lot numbers. These products were distributed nationwide through six U.S. distributors, affecting approximately 26,925 units total. Healthcare providers and users should identify affected products by comparing their part number and lot code against the FDA recall notice.
Compromised sterility in medical devices can result in contamination or infection risk during use. Healthcare providers and users should immediately discontinue use of any affected units and follow appropriate protocols for safe disposal of recalled medical devices.
Anyone with questions about the specific part numbers and lot codes involved in this recall should contact Quanta System or their authorized distributor.
The recalled product
- Product
- Olympus Sterile Optical Laser Fiber, single use and reusable
- Manufacturer
- Quanta System, S.p.A.
- Hazard
- sterility-compromise
- infection-risk
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 (20)
- Product Part Numbers: OFH302721 - lots H182604
- H182605
- H184521
- H204109
- H204110
- H204111
- H204112 OFH002711 - lots H182606
- H182607
- H182608
- H182609
- H182701
- H182702
- H182703
- H182704
- H182709
- H204113
- H204114
- H204115
- H204116
- H204117
Distribution
Distributed nationwide across the United States.
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