FDAClass IIMay 29, 2024

InstaClear Lens Sheath. The InstaClear lens cleaner recall

InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly…

Why was InstaClear Lens Sheath. The InstaClear lens cleaner recalled?

Potential for distal end of the sheath to break off during a procedure.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model No. LCS4K30BTOL, LCS1530TPOL, LCS1830TPST, LCS4K30TPOL, LCS1545BTOL, LCS1845BTST, LCS4K45BTOL, LCS1545TPOL, LCS1845TPST, LCS4K45TPOL, LCS1570BTOL, LCS1870BTST, LCS4K70BTOL, LCS1570TPOL, LCS1870TPST, LCS4K70TPOL; UDI-DI: 00821925040137, 00821925040151, 00821925040144, 00821925040175, 00821925040168, 00821925040199, 00821925040182, 00821925040083, 00821925040076, 00821925040106, 00821925040090, 00821925040120, 00821925040113, 00821925040069; All Lot Numbers.

Product
InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly…
Recalling firm
Olympus Corporation of the Americas
Quantity
pending
Distribution
Domestic: Nationwide Distribution; Foreign: Australia, Canada, Germany, Japan.
Recall date
May 29, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls