Rocket Medical Plc recalls Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Softw…

Recall date

November 7, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0954-2026

FDA classification

Class II

Brand / firm

Rocket Medical Plc

Sold / distributed

Domestic: CO, CT, IL, MA, ME, NH, NJ, NM, OH, RI, SC, TX; International: UAE, Austria, Australia, Canada, Germany, Denmark, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, India, Italy, Jersey, Kenya, Sri Lanka, Malta, Netherlands, Norway, New Zealand, Portugal, Saudi Arabia, S…

Why it was recalled

IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A