Olympus Single Use Guide Sheath Kits Recalled for Tip Detachment Risk

Agency Publication Date: February 11, 2025

Summary

Olympus Corporation of the Americas is recalling 454 units of its Single Use Guide Sheath Kits (Models K-201, K-202, K-203, and K-204). These medical kits, which include components like guide sheaths, biopsy forceps, and cytology brushes, are used to collect tissue specimens from a patient's respiratory system. The recall was issued because the radiopaque tip of the guide sheath may detach and fall off into the patient during a medical procedure. Healthcare providers are advised to stop using these kits and contact Olympus to arrange for a return or replacement.

Risk

The radiopaque tip of the guide sheath can break off and remain inside the patient's body during respiratory procedures. This poses a significant risk of internal injury or medical complications if the detached component is not successfully retrieved.

What You Should Do

This recall affects Olympus Single Use Guide Sheath Kits sold under model numbers K-201, K-202, K-203, and K-204.
Identify affected products by checking the model number and Unique Device Identifier (UDI-DI) on the device packaging: 04953170245466 (K-201), 04953170245480 (K-202), 04953170245503 (K-203), or 04953170245527 (K-204). All lots for these models are included in the recall.
Stop using the recalled devices immediately and remove them from clinical inventory to prevent patient harm.
Contact Olympus Corporation of the Americas or your authorized medical distributor to arrange for the return, replacement, or correction of the affected units.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit the FDA medical device recall website for additional information.

Your Remedy Options

Other Action

Clinical Device Corrective Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Single Use Guide Sheath Kit K-201 2.0MM Channel Set

Variants: Guide Sheath, Biopsy Forceps, Cytology Brush

Model / REF:

K-201

UDI:

04953170245466

All Lots included.

Product: Single Use Guide Sheath Kit K-202 2.0MM Channel Set

Variants: Guide Sheath, Biopsy Forceps

Model / REF:

K-202

UDI:

04953170245480

All Lots included.

Product: Single Use Guide Sheath Kit K-203 2.6MM Channel Set

Variants: Guide Sheath, Biopsy Forceps, Cytology Brush

Model / REF:

K-203

UDI:

04953170245503

All Lots included.

Product: Single Use Guide Sheath Kit K-204 2.6MM Channel Set

Variants: Guide Sheath, Biopsy Forceps

Model / REF:

K-204

UDI:

04953170245527

All Lots included.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96087

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Authorized Medical Distributors; Direct Sales to Healthcare Facilities

Manufactured In: United States

Units Affected: 454 units

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Olympus Single Use Guide Sheath Kits sold under model numbers K-201, K-202, K-203, and K-204.

Identify affected products by checking the model number and Unique Device Identifier (UDI-DI) on the device packaging: 04953170245466 (K-201), 04953170245480 (K-202), 04953170245503 (K-203), or 04953170245527 (K-204). All lots for these models are included in the recall.

Stop using the recalled devices immediately and remove them from clinical inventory to prevent patient harm.

Contact Olympus Corporation of the Americas or your authorized medical distributor to arrange for the return, replacement, or correction of the affected units.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit the FDA medical device recall website for additional information.

Affected Products

Product: Single Use Guide Sheath Kit K-201 2.0MM Channel Set

Variants: Guide Sheath, Biopsy Forceps, Cytology Brush

Model / REF:

K-201

UDI:

04953170245466

All Lots included.

Product: Single Use Guide Sheath Kit K-202 2.0MM Channel Set

Variants: Guide Sheath, Biopsy Forceps

Model / REF:

K-202

UDI:

04953170245480

All Lots included.

Product: Single Use Guide Sheath Kit K-203 2.6MM Channel Set

Variants: Guide Sheath, Biopsy Forceps, Cytology Brush

Model / REF:

K-203

UDI:

04953170245503

All Lots included.

Product: Single Use Guide Sheath Kit K-204 2.6MM Channel Set

Variants: Guide Sheath, Biopsy Forceps

Model / REF:

K-204

UDI:

04953170245527

All Lots included.