Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Surgical Equipment

Rocket Seldinger Catheter Kits Recalled for Misleading Labeling and Fall-Out Risk

Agency Publication Date: December 18, 2025
Share:
Sign in to monitor this recall

Summary

Rocket Medical Plc has recalled 2,701 units of various Rocket Seldinger Catheter Procedure Trays and Catheters with Safety Guards. The instructions for use and kit labeling for these medical devices contain misleading statements that can lead to the catheter being improperly secured during insertion. If the device is not secured correctly, there is a risk that it could fall out while in use on a patient. This voluntary recall includes several catalog numbers for 12Fg, 16Fg, 18Fg, and 20Fg sizes.

Risk

If a chest catheter is improperly secured, it may become loose or fall out entirely during a medical procedure. This could lead to a failure to drain fluid or air properly from the chest cavity, or could allow air to enter the cavity, potentially causing serious respiratory complications for the patient.

What You Should Do

  1. This recall affects various Rocket Seldinger Catheter kits, including 12Fg, 16Fg, 18Fg, and 20Fg procedure trays and safety guard models (Catalog numbers R54544-12-PK, R54544-12-SG, R54544-18-PK, R54544-18-SG, R54549-16-PK, and R54549-20-PK). See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled medical devices immediately.
  3. Contact the manufacturer, Rocket Medical Plc, or your distributor to arrange for the return, replacement, or correction of the products.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions or to report adverse events.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Rocket 12Fg Seldinger Catheter Procedure Trayby Rocket
Variants: 12Fg size
Model / REF:
R54544-12-PK
Lot Numbers:
496708
501186
496903
501548
497147
502122
497292
502317
497344
502534
497664
502949
499226
503201
499276
503429
499415
503732
499462
503899
499806
503935
499902
504283
500404
504581
500474
504637
500757
504821
500955
505025
UDI:
050552709TF06DXY

Chest tube manufactured from PVC, with fenestrations and a barium stripe. Supplied with procedure pack.

Product: Rocket 12Fg Seldinger Catheter with Safety Guardby Rocket
Variants: 12Fg size
Model / REF:
R54544-12-SG
Lot Numbers:
497012
502660
497561
502780
497763
502978
498069
503202
499335
503384
499541
503406
499903
503536
500405
503733
500630
503900
500706
504179
500812
504397
501030
504628
501615
504822
UDI:
050552709TF06DXY

Chest tube manufactured from PVC, with fenestrations and a barium stripe. Supplied with procedure pack.

Product: Rocket 18Fg Seldinger Catheter Procedure Trayby Rocket
Variants: 18Fg size
Model / REF:
R54544-18-PK
Lot Numbers:
496899
500956
497076
501169
497584
501188
499227
502430
499417
502951
499461
503306
499897
503430
499898
503529
499899
504180
499908
504543
500407
504823
500477
UDI:
050552709TF06DXY

Chest tube manufactured from PVC, with fenestrations and a barium stripe. Supplied with procedure pack.

Product: Rocket 18Fg Seldinger Catheter with Safety Guardby Rocket
Variants: 18Fg size
Model / REF:
R54544-18-SG
Lot Numbers:
496809
501616
497346
501710
497665
502431
498972
503735
499909
503937
500782
504573
501256
504824
UDI:
050552709TF06DXY

Chest tube manufactured from PVC, with fenestrations and a barium stripe. Supplied with procedure pack.

Product: Rocket 16Fg Seldinger Catheter Procedure Trayby Rocket
Variants: 16Fg size
Model / REF:
R54549-16-PK
Lot Numbers:
496659
497629
496918
499814
497077
500408
UDI:
050552709TF06DXY

Chest tube manufactured from PVC, with fenestrations and a barium stripe. Supplied with procedure pack.

Product: Rocket 20Fg Seldinger Catheter Procedure Trayby Rocket
Variants: 20Fg size
Model / REF:
R54549-20-PK
Lot Numbers:
496455
499910
496811
500480
496919
501734
497516
503706
499083
504152
UDI:
050552709TF06DXY

Chest tube manufactured from PVC, with fenestrations and a barium stripe. Supplied with procedure pack.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97994
Status: Active
Manufacturer: Rocket Medical Plc
Sold By: Medical distributors; Hospitals; Surgical centers
Manufactured In: United Kingdom
Units Affected: 6 products (635 units; 240 units; 630 units; 110 units; 840 units; 246 units)
Distributed To: Colorado, Connecticut, Illinois, Massachusetts, Maine, New Hampshire, New Jersey, New Mexico, Ohio, Rhode Island, South Carolina, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.