Z-1762-2020Class II

Olympus Pleuravideoscope, Model LTF-160

Name: Z-1762-2020 Olympus Pleuravideoscope, Model LTF-160
Creator: Olympus Corporation of the Americas
Published: 2020-03-23
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2020-03-23 / Terminated

FDA source

Olympus Corporation of the Americas began a recall of Olympus Pleuravideoscope, Model LTF-160 on 2020-03-23. FDA classified it as Class II and gives the reason as "There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1762-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-23
Posted: 2020-04-22
Terminated: 2021-11-30
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus Pleuravideoscope, Model LTF-160
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided.
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Correction notification letter dated 3/23/20 was sent to customers. Actions to be taken by the user: Our records indicate that your facility has purchased one or more of the above-referenced endoscopes. OLYMPUS requires that you take the following actions: a) Inspect your inventory of operation manuals for the referenced Olympus models and discard the existing ones. b) Exchange them with the updated, enclosed Operation Manuals having an updated system chart indicating compatible endoscope accessories. c) Notify related personnel at your institution that they should stop the combination use of the LTF-160 and LTF-240 and the subject Endo-Therapy accessories. d) Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0066 and provide your contact information as indicated in the portal. e) If you have further distributed this product, identify your customers, forward them this notification including the attachments, and appropriately document your notification process. Olympus regrets any inconvenience caused and fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly at (484)896-5688 from Monday till Friday 8AM ET to 5PM ET or by e-mail at [email protected].
Quantity in commerce: 265 total
Distribution: US Nationwide
Product codes and lots: All Serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1762-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1762-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-22
Z-1763-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-22

Product code GCJ

K013617Class IILtf-240 Pleuravideoscope, Its Accessories and Ancillary EquipmentsOlympus Optical Co., Ltd. / cleared 2002-01-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)