The Recall Desk

FDA (Devices) recall action 97994

Rocket Medical Plc recalled 6 products on 2025-12-24

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2025-12-24
Critical
0
Units
2,701

Why these products were recalled

IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–6 of 6

  • HighFDA (Devices)··2025-12-24

    Twenty French chest tube trays recalled over misleading securing instructions

    Rocket Medical is recalling 246 Rocket 20Fg Seldinger Catheter Procedure Trays because the instructions and kit labeling contain misleading statements that can lead to improper securing.

    Product
    Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-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 w
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2025-12-24

    Eighteen French catheters with safety guard recalled over misleading securing instructions

    Rocket Medical is recalling 110 Rocket 18Fg Seldinger Catheters with Safety Guard because the instructions and kit labeling contain misleading statements that can lead to improper securing.

    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. Supplie
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2025-12-24

    Sixteen French chest tube trays recalled over misleading securing instructions

    Rocket Medical is recalling 840 Rocket 16Fg Seldinger Catheter Procedure Trays because the instructions and kit labeling contain misleading statements that can lead to improper securing.

    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 w
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2025-12-24

    Twelve French catheters with safety guard recalled over misleading securing instructions

    Rocket Medical is recalling 240 Rocket 12Fg Seldinger Catheters with Safety Guard because the instructions and kit labeling contain misleading statements that can lead to improper securing.

    Product
    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. Supplie
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2025-12-24

    Chest tube procedure trays recalled over misleading instructions for securing the device

    Rocket Medical is recalling 630 Rocket 18Fg Seldinger Catheter Procedure Trays because the instructions and kit labeling contain misleading statements that can lead to improper securing.

    Product
    Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-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 w
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2025-12-24

    Twelve French chest tube trays recalled over misleading securing instructions

    Rocket Medical is recalling 635 Rocket 12Fg Seldinger Catheter Procedure Trays because the instructions and kit labeling contain misleading statements that can lead to improper securing.

    Product
    Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK 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
    Category
    Distribution
    12 states