Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog...
FDA Device Recall #Z-0951-2026 — Class II — November 7, 2025
Recall Summary
| Recall Number | Z-0951-2026 |
| 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 | 240 units |
Product Description
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-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. Component: N/A
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: R54544-12-SG; UDI-DI: 050552709TF06DXY; Lot Code: 497012, 502660, 497561, 502780, 497763, 502978, 498069, 503202, 499335, 503384, 499541, 503406, 499903, 503536, 500405, 503733, 500630, 503900, 500706, 504179, 500812, 504397, 501030, 504628, 501615, 504822;
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-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 |
| Z-0953-2026 | Class II | Brand Name: Rocket Product Name: Rocket 18Fg 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.