Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog...

FDA Device Recall #Z-0953-2026 — Class II — November 7, 2025

Recall Summary

Recall Number Z-0953-2026
Classification Class II — Moderate risk
Date Initiated November 7, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Rocket Medical Plc
Location Tyne & Wear
Product Type Devices
Quantity 110 units

Product Description

Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG 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.

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.

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

Lot / Code Information

Model/Catalog Number: R54544-18-SG; UDI-DI: 050552709TF06DXY; Lot Code: 496809, 501616, 497346, 501710, 497665, 502431, 498972, 503735, 499909, 503937, 500782, 504573, 501256, 504824;

Other Recalls from Rocket Medical Plc

Recall # Classification Product Date
Z-0954-2026 Class II Brand Name: Rocket Product Name: Rocket 16Fg S... Nov 7, 2025
Z-0955-2026 Class II Brand Name: Rocket Product Name: Rocket 20Fg S... Nov 7, 2025
Z-0951-2026 Class II Brand Name: Rocket Product Name: Rocket 12Fg S... Nov 7, 2025
Z-0952-2026 Class II Brand Name: Rocket Product Name: Rocket 18Fg S... Nov 7, 2025
Z-0950-2026 Class II Brand Name: Rocket Product Name: Rocket 12Fg S... Nov 7, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.