The Recall Desk
HighFDA (Devices)·Z-0953-2026·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states misleading instructions can lead to a chest tube falling out during use, and no injuries are reported.

Plain-English summary

The Rocket 18Fg Seldinger Catheter with Safety Guard, model R54544-18-SG, is being recalled by Rocket Medical Plc. The product is a chest tube manufactured from PVC with fenestrations and a barium stripe.

The instructions for use and device kit labeling contain misleading statements leading to improper securing of the device, resulting in the potential for it to fall out during use.

The record lists 110 units carrying UDI-DI 050552709TF06DXY, across lot codes including 496809, 501616, 497346, 501710 and 497665. Domestic distribution covered Colorado, Connecticut, Illinois, Massachusetts, Maine, New Hampshire, New Jersey, New Mexico, Ohio, Rhode Island, South Carolina and Texas, with international distribution including the United Arab Emirates, Austria, Australia, Canada and Germany. The FDA has classified the action as Class II.

The enforcement record reports no injuries. Facilities should follow Rocket Medical's instructions.

The recalled product

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
Manufacturer
Rocket Medical Plc
Category
Medical Device — Chest drainage
Hazard
Affected units
110

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • Model/Catalog Number: R54544-18-SG
  • UDI-DI: 050552709TF06DXY
  • Lot Code: 496809
  • 501616
  • 497346
  • 501710
  • 497665
  • 502431
  • 498972
  • 503735
  • 499909
  • 503937
  • 500782
  • 504573
  • 501256
  • 504824

Distribution

Distributed in 12 states:

Part of a larger recall action

This product is one of 6 recalled by Rocket Medical Plc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Rocket Medical Plc

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