Rocket Medical Plc
FDA Regulatory Profile
Rocket Medical Plc appears in FDA public data with 7 recalls, 19 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0954-2026, Class II) was initiated on November 7, 2025. Its most recent 510(k) clearance was granted on September 9, 2021.
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 19
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0954-2026 | Class II | Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Numbe | November 7, 2025 |
| Z-0951-2026 | Class II | Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Nu | November 7, 2025 |
| Z-0953-2026 | Class II | Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Nu | November 7, 2025 |
| Z-0952-2026 | Class II | Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Numbe | November 7, 2025 |
| Z-0950-2026 | Class II | Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Numbe | November 7, 2025 |
| Z-0955-2026 | Class II | Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Numbe | November 7, 2025 |
| Z-0512-2020 | Class II | Rocket KCH Fetal Bladder Drainage Catheter Model: R57405 | August 1, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K210509 | Rocket Platinum Cured Cathter | September 9, 2021 |
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | August 17, 2017 |
| K162457 | Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit | November 14, 2016 |
| K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set | March 29, 2016 |
| K123033 | ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, R | February 1, 2013 |
| K052365 | CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE | October 17, 2005 |
| K042264 | GUIDEWIRES | November 24, 2004 |
| K040189 | ENDOMETRIAL SAMPLING SYRINGE | October 4, 2004 |
| K032015 | EMBRYON ULTRASOUND NEEDLE GUIDE | August 8, 2003 |
| K000340 | HYSTALOG HSG CATHETER | April 19, 2000 |
| K000205 | EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES | April 19, 2000 |
| K994344 | NEUROTHERM RF CANNULA | March 21, 2000 |
| K000656 | EMBRYON GIFT TRANSFER CATHETERS/SETS | March 9, 2000 |
| K000394 | CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT | February 29, 2000 |
| K994327 | EMBRYON TRANSFER CATHETERS/SETS | February 28, 2000 |
| K980061 | EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET F | March 2, 1998 |
| K972856 | ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS | February 11, 1998 |
| K972867 | CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT | October 24, 1997 |
| K961287 | ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM | July 26, 1996 |