Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Gore Tips Set Device Recalled by Creganna Medical Devices Due to Three lots of product may be labeled with...

Date: June 22, 2023
Company: Creganna Medical Devices
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Creganna Medical Devices directly.

Affected Products

Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access

Quantity: 194 units

Why Was This Recalled?

Three lots of product may be labeled with an incorrect expiration day

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Creganna Medical Devices

Creganna Medical Devices has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report