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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97994

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 07, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Rocket Medical Plc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

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

Z-0950-2026
Recall number
Z-0950-2026
Initiated
November 07, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Rocket Medical Plc
Quantity
635 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model/Catalog Number: R54544-12-PK; UDI-DI: 050552709TF06DXY; Lot Code: 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;

Distribution pattern

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

device · product 2 of 6

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

Z-0951-2026
Recall number
Z-0951-2026
Initiated
November 07, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Rocket Medical Plc
Quantity
240 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model/Catalog Number: R54544-12-SG; UDI-DI: 050552709TF06DXY; Lot Code: 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;

Distribution pattern

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

device · product 3 of 6

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

Z-0952-2026
Recall number
Z-0952-2026
Initiated
November 07, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Rocket Medical Plc
Quantity
630 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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;

Distribution pattern

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

device · product 4 of 6

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. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices.

Z-0953-2026
Recall number
Z-0953-2026
Initiated
November 07, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Rocket Medical Plc
Quantity
110 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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 pattern

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

device · product 5 of 6

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

Z-0954-2026
Recall number
Z-0954-2026
Initiated
November 07, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Rocket Medical Plc
Quantity
840 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model/Catalog Number: R54549-16-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496659, 497629, 496918, 499814, 497077, 500408;

Distribution pattern

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

device · product 6 of 6

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

Z-0955-2026
Recall number
Z-0955-2026
Initiated
November 07, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Rocket Medical Plc
Quantity
246 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model/Catalog Number: R54549-20-PK; UDI-DI: 050552709TF06DXY; Lot Code: 496455, 499910, 496811, 500480, 496919, 501734, 497516, 503706, 499083, 504152;

Distribution pattern

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