Z-1888-2024Class II

InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of...

Name: Z-1888-2024 InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of...
Creator: Olympus Corporation of the Americas
Published: 2024-04-03
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-04-03 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery... on 2024-04-03. FDA classified it as Class II and gives the reason as "Potential for distal end of the sheath to break off during a procedure". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1888-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-03
Posted: 2024-05-23
Recalling firm: OLYMPUS Corporation of the Americas
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.
Product code: EOB Nasopharyngoscope (Flexible Or Rigid)
Reason for recall: Potential for distal end of the sheath to break off during a procedure.
FDA 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, Option 1. Consignees with any questions can contact Olympus at 647-999-3203 or by email at [email protected].
Quantity in commerce: pending
Distribution: Domestic: Nationwide Distribution; Foreign: Australia, Canada, Germany, Japan.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1888-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1888-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-29	2024-05-23

Product code EOB

K152531Class IIInstaClear Lens CleanerGyrus Acmi, Inc. / cleared 2016-01-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)