Class II U.S. Food and Drug Administration

Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter recall: IFU and device kit labeling contains misleading statements leading

Recall published 10 months ago

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 hazard: Fall or tip-over hazard

The recall is about structural failure — a frame, joint, leg or lock that does not hold under ordinary use.

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

Why it matters: The product can tip, collapse or give way under normal use. Furniture tip-overs in particular kill and injure young children, usually when a child climbs on an open drawer.

Symptoms and when to call a doctor

After a fall or a tip-over involving a child, watch for a headache that gets worse, repeated vomiting, drowsiness that is hard to rouse, confusion, unequal pupils, clear fluid from the nose or ear, or a seizure, and call 911 if any of these appear. Any fall onto the head in a baby under one, or any loss of consciousness at any age, needs to be assessed the same day.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0954-2026
Published
December 24, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Rocket Medical Plc
Product type
Medical devices
Units affected
840 units
Distribution
Colorado, Connecticut, Illinois, Massachusetts, Maine, New Hampshire, New Jersey, New Mexico, Ohio, Rhode Island, South Carolina, Texas
Made in
United Kingdom
Lot / code info
Model/Catalog Number: R54549-16-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496659, 497629, 496918, 499814, 497077, 500408;

Products covered by this recall

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

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 496659
  • 497629
  • 496918
  • 499814
  • 497077
  • 500408

Model or item number

On the rating label, the box or the instruction sheet.

  • R54549-16-PK Software Version
  • R54549-16-PK

Package size

Match the net weight or the piece count on the front of the pack.

  • 16 PK

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Fall

Rocket Medical Plc — The recall is about structural failure — a frame, joint, leg or lock that does not hold under ordinary use.

  1. Stop using the product and, if it is furniture, move it out of a child’s room until the remedy is done.
  2. Anchor tall furniture to the wall with a tip-over restraint — this is worth doing for every chest and bookcase in the house, not just this one.
  3. Keep TVs, toys and anything else tempting off the top of tall furniture, because that is what draws a child to climb.
  4. Inspect similar units from the same range, since a weak joint or fastener usually affects a whole production run.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.
  • A replacement is usually the current model, not the recalled one. Confirm the replacement is not itself under recall.

Company contact: Rocket Medical Plc — Industrial Estate Sedling Road Wear Industrial Estate, Tyne & Wear

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Rocket Medical Plc medical devices 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. IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 496659, 497629, 496918; model number R54549-16-PK Software Version, R54549-16-PK. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the product and, if it is furniture, move it out of a child’s room until the remedy is done.

Can I get my money back?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

Which states were affected?

The notice lists Colorado, Connecticut, Illinois, Massachusetts, Maine, New Hampshire, New Jersey, New Mexico, Ohio, Rhode Island, South Carolina, Texas.

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