Class II — Rocket Medical Plc
| Recalling firm | Rocket Medical Plc |
|---|---|
| Registered facility | ROCKET MEDICAL PLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | 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. |
| Quantity | 110 units |
| 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 |
| Initiated | 2025-11-07 |
| Classified | 2025-12-18 |
| Recall number | Z-0953-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Rocket Medical Plc (Z-0953-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97994/
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