Recall Z-1888-2024 ยท EOB Nasopharyngoscope (Flexible Or Rigid)
Olympus Corporation of the Americas
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.
| Date | May 23, 2024 (initiated Apr 3, 2024) |
| Status | Open, Classified |
| Reason | Potential for distal end of the sheath to break off during a procedure. |
| Root cause | Under Investigation by firm |
| Action | Consignees were mailed an URGENT MEDICAL DEVICE CORRECTION notification, dated 5/1/24. Consignees are instructed to read the provided labeling addendum, inspect their inventory to identify affected devices and place a copy of the addendum with the remaining inventory, ensure all required personnel are aware of this recall, notify those who received product further distributed, and acknowledge receipt of the recall notification using Olympus's recall portal. Consignees can report the incidence of a device breakage associated with this event to the Technical Assistance Center at 1-800-8489024, O |
| Quantity | pending |
| Distribution | Domestic: Nationwide Distribution; Foreign: Australia, Canada, Germany, Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152531 | InstaClear Lens Cleaner Gyrus Acmi, Inc., Jan 15, 2016 |