Rocket Medical Plc: Medical Device Recall in 2025 - (Recall #: Z-0954-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: November 7, 2025

Date Posted: December 24, 2025

Recall Number: Z-0954-2026

Event ID: 97994

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.

Status: Ongoing

Product Quantity: 840 units

Code Information:

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

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

Voluntary or Mandated:

Voluntary: Firm initiated