FDA Device recall Z-0954-2026
Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Pro…
- FDA Device
- Class II
- ongoing
- Published 2025-12-24
On 2025-12-24 the FDA classified a Class II recall of Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Pro… by Rocket Medical, citing IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0954-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-07 |
| Published | 2025-12-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Rocket Medical |
| Distribution | CO, CT, IL, MA, ME, NH, NJ, NM, OH, RI, SC, TX |
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.
Identifiers
| code_info | Model/Catalog Number: R54549-16-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496659, 497629, 496918, 499814, 497077, 500408; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0954-2026%22
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