Rocket Medical Plc: Device Recall

Recall #Z-0954-2026 · 11/07/2025

Class II: Risk

Recall Details

Recall Number: Z-0954-2026
Classification: Class II
Product Type: Device
Recalling Firm: Rocket Medical Plc
Status: Ongoing
Date Initiated: 11/07/2025
Location: Tyne & Wear, United Kingdom
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 840 units

Reason for Recall

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

Product Description

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

Distribution Pattern

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, Singapore, Slovenia, South Africa

Other Recalls by Rocket Medical Plc

Class II: Risk 11/07/2025

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: Risk 11/07/2025

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: Risk 11/07/2025

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: Risk 11/07/2025

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: Risk 11/07/2025

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

View all recalls by Rocket Medical Plc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.