Rocket Medical Plc recalls Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray

Recalling company

Rocket Medical Plc

Product

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

Reason

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

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Nov 7, 2025

Reported

Dec 24, 2025

Distribution

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

Status

Ongoing

Quantity

840 units

Lot / codes

Model/Catalog Number: R54549-16-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496659, 497629, 496918, 499814, 497077, 500408;

Company location

Tyne & Wear

Recall type

Voluntary: Firm initiated

Recall number

Z-0954-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0954-2026 in the FDA Enforcement Report. Also see FDA recall press releases.