FDA recall Z-1888-2024

Olympus Corporation of the Americas · Class II · device

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.

Reason for recall

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

Distribution

Domestic: Nationwide Distribution; Foreign: Australia, Canada, Germany, Japan.

Key facts

Status
Ongoing
Initiation date
2024-04-03
Report date
2024-05-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1888-2024