Z-0645-2024Class II

OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system...

Name: Z-0645-2024 OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system...
Creator: Olympus Corporation of the Americas
Published: 2023-11-20
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-11-20 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation equipment... on 2023-11-20. FDA classified it as Class II and gives the reason as "Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0645-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-20
Posted: 2024-01-05
Recalling firm: OLYMPUS Corporation of the Americas
Product: OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.
Product code: HET Laparoscope, Gynecologic (And Accessories)
Reason for recall: Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Olympus Medical Systems Corporation issued Urgent Medical Device Correction Letter on November 20, 2023. Letter states reason for recall, health risk and action to take: Olympus requires you to take the following actions: During an evaluation of user implementation of the Instructions for Use related to the reprocessing of the LTF-S190-5 videoscope, Olympus observed deviations from the following reprocessing steps detailed in the respective Reprocessing Manual Instructions. These steps are required for the proper reprocessing of these videoscopes. Therefore, Olympus is reminding users that following the instructions in these reprocessing manuals (LTF-S190-5 Reprocessing Manual, GE9382, and LTF-S190-10 Reprocessing Manual, RC0686) is required. Olympus is offering educational on-site support to review and train on the reprocessing instructions for the LTF-S190-5 and LTF-S190-10. The LTF-S190-10 is similar in design to the LTF-S190-5 and is therefore included in this corrective action 1. Carefully read the contents of this notification. 2. Ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the reprocessing instructions contained in Sections 5.5, 5.6, and 5.7 of the LTF Reprocessing Manuals, especially adhering to the immersion time for the entire endoscope, and the brushing or wiping steps. 3. If you have further distributed this product, forward this letter to those facilities immediately. 4. Olympus requests that you acknowledge receipt of this letter. Complete the enclosed response form and return it to our recall partner, Sedgwick, via e-mail at [email protected] or by fax at 844-265-7383. For any questions about the acknowledgement form, please call the Sedgwick team at 844-483-3866. If you require additional information about the proper steps to reprocess, Olympus provides the following resources: Contact your local Olympus Endoscopy Support Specialist (ESS) or our Technical Assistance Center for assistance in ar
Quantity in commerce: 271 units US
Distribution: Nationwide
Product codes and lots: UDI-DI: 04953170310386 All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0645-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0644-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0645-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05

Product code HET

K111425Class IIOlympus Ltf-S190-10, Olumpus Otv-S190, Olympus Clv-S190Olympus Medical Systems Corp. / cleared 2012-04-20

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)