CLASS II ONGOING Device recall · Reported 24 Dec 2025 · FDA Enforcement Report

Rocket 18Fg Seldinger Catheter Procedure Tray recalled by Rocket Medical

Rocket Medical is recalling Rocket 18Fg Seldinger Catheter Procedure Tray, distributed nationwide in the US. The recall was initiated on 7 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog Number: R54544-18-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496899, 500956, 497076, 501169, 497584, 501188, 499227, 502430, 499417, 502951, 499461, 503306, 499897, 503430, 499898, 503529, 499899, 504180, 499908, 504543, 500407, 504823, 500477;

Quantity recalled630 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0952-2026
FDA event ID: 97994
Recalling firm: Rocket Medical, Tyne & Wear
Classification: Class II
Status: Ongoing
Recall initiated: 7 Nov 2025
FDA classified: 18 Dec 2025
Reported: 24 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

7 Nov 2025	Recall initiated by company
18 Dec 2025	Classified by FDA	+41 days
24 Dec 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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 with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

Where it was distributed

Domestic: CO, CT, IL, MA, ME, NH, NJ, NM, OH, RI, SC, TX; International: UAE, Austria, Australia, Canada, Germany, Denmark, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, India, Italy, Jersey, Kenya, Sri Lanka, Malta, Netherlands, Norway, New Zealand, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa

Nationwide Colorado Connecticut Illinois Massachusetts Maine New Hampshire New Jersey New Mexico Ohio Rhode Island South Carolina Texas

Questions about this recall

Is Rocket 18Fg Seldinger Catheter Procedure Tray recalled?

Yes. Rocket Medical recalled Rocket 18Fg Seldinger Catheter Procedure Tray on 7 Nov 2025. The recall is Class II and its status is Ongoing. Recall number Z-0952-2026.

Why was it 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.

Which lots are affected?

Model/Catalog Number: R54544-18-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496899, 500956, 497076, 501169, 497584, 501188, 499227, 502430, 499417, 502951, 499461, 503306, 499897, 503430, 499898, 503529, 499899, 504180, 499908, 504543, 500407, 504823, 500477;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Rocket Medical

All 7

Reported	Class	Recall	Company	Reason	Where
24 Dec 2025Device	CLASS II	Rocket 18Fg Seldinger Catheter with Safety Guard recalled	Rocket Medical	Device Malfunction	Nationwide
24 Dec 2025Device	CLASS II	Rocket 12Fg Seldinger Catheter Procedure Tray recalled by Rocket Medical	Rocket Medical	Other	Nationwide
24 Dec 2025Device	CLASS II	Rocket 12Fg Seldinger Catheter with Safety Guard recalled	Rocket Medical	Device Malfunction	Nationwide
24 Dec 2025Device	CLASS II	Rocket 20Fg Seldinger Catheter Procedure Tray recalled by Rocket Medical	Rocket Medical	Device Malfunction	Nationwide
24 Dec 2025Device	CLASS II	Rocket 16Fg Seldinger Catheter Procedure Tray recalled by Rocket Medical	Rocket Medical	Device Malfunction	Nationwide

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16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide