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InstaClear recallZ-1888-2024 · Olympus Corporation of the Americas · initiated Apr 3, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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].

Recall details

Recall number
Z-1888-2024
Status
Open, Classified
Initiated by the company
Apr 3, 2024
Posted by the FDA
May 23, 2024
Recalling firm
Olympus Corporation of the Americas
Quantity
pending
Product code
EOB
FDA submissions
K152531
Distribution
Domestic: Nationwide Distribution; Foreign: Australia, Canada, Germany, Japan.

Product description

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.

Code information (models, lots, serial numbers)

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.

Devices named in this recall

14 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

5 devices cleared under K152531 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page