Z-1071-2025Class I

Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use...

Name: Z-1071-2025 Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use...
Creator: Olympus Corporation of the Americas
Published: 2025-01-15
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2025-01-15 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide... on 2025-01-15. FDA classified it as Class I and gives the reason as "Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1071-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-01-15
Posted: 2025-02-11
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201 2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-202 3. Single Use Guide Sheath Kit K-203 2.6MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-203 4. Single Use Guide Sheath Kit K-204 2.6MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-204. Used to collect cells or tissue specimens in the respiratory organs.
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
FDA root cause: Under Investigation by firm
Action: Olympus notified consignees on about 01/15/2024, via letter. Consignees were instructed to examine inventory and quarantine affected devices, cease usage of the product immediately, acknowledge receipt of the letter through the Olympus web portal, and to forward the notice to all applicable personnel and customers if further distributed.
Quantity in commerce: 454 units
Distribution: US nationwide distribution.
Product codes and lots: 1. Model Number: K-201; UDI-DI: 04953170245466; All Lots. 2. Model Number: K-202; UDI-DI: 04953170245480; All Lots 3. Model Number: K-203; UDI-DI: 04953170245503; All Lots 4. Model Number: K-204; UDI-DI: 04953170245527; All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1071-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1071-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-11

Product code EOQ

K060243Class IIOlympus Guide Sheath, Model Xbo1-836-13Olympus Medical Systems Corporation / cleared 2006-06-23

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)