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Open, Classified

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.

FDA Recall Z-1888-2024 · Posted 2024-05-23

Recall StatusOpen, Classified
Product CodeEOB
Date Initiated2024-04-03
Product Quantitypending

Reason for Recall

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

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, Option 1. Consignees with any questions can contact Olympus at 647-999-3203 or by email at [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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