AllClear
PricingSign in
FDAJanuary 15, 2025device

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 Fo...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

04953170245466049531702454800495317024550304953170245527

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →