Olympus InstaClear Lens Sheath Recalled for Potential Distal End Breakage
Olympus has recalled InstaClear Lens Sheaths used in rigid endoscopy because the distal end may break off during procedures. All lot numbers of multiple model variants distributed in the U.S. and internationally are affected.
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 medical device recall with potential for breakage during use. No illnesses or injuries have been reported—only theoretical risk. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, placing it at High severity.
Plain-English summary
Olympus Corporation of the Americas is recalling InstaClear Lens Sheaths, which are used to clean and clear the lens of rigid endoscopes during nasal surgical procedures without requiring removal from the nasal cavity.
The sheaths are being recalled because of the potential for the distal end to break off during a procedure. The recall affects all lot numbers of multiple model numbers including LCS4K30BTOL, LCS1530TPOL, LCS1830TPST, LCS4K30TPOL, LCS1545BTOL, LCS1845BTST, LCS4K45BTOL, LCS1545TPOL, LCS1845TPST, LCS4K45TPOL, LCS1570BTOL, LCS1870BTST, LCS4K70BTOL, LCS1570TPOL, and LCS1870TPST. These devices have been distributed domestically throughout the United States and internationally to Australia, Canada, Germany, and Japan.
The recalled product
- Product
- InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.
- Manufacturer
- Olympus Corporation of the Americas
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)
- Model No. LCS4K30BTOL
- LCS1530TPOL
- LCS1830TPST
- LCS4K30TPOL
- LCS1545BTOL
- LCS1845BTST
- LCS4K45BTOL
- LCS1545TPOL
- LCS1845TPST
- LCS4K45TPOL
- LCS1570BTOL
- LCS1870BTST
- LCS4K70BTOL
- LCS1570TPOL
- LCS1870TPST
- LCS4K70TPOL
- UDI-DI: 00821925040137
- 00821925040151
- 00821925040144
- 00821925040175
Distribution
Distributed nationwide across the United States.
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