Browse recalls
Issuing authority: US FDA — Medical Devices
- 2025-03-24 · US FDA — Medical DevicesClass II
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure - 2025-03-24 · US FDA — Medical DevicesClass II
SmartPath to dStream for 1.5T, Model Number: 782146; - 2025-03-24 · US FDA — Medical DevicesClass II
IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure g - 2025-03-24 · US FDA — Medical DevicesClass II
Intera 1.0T Omni/Stellar, Model Number: 781102; - 2025-03-24 · US FDA — Medical DevicesClass II
Enterprise 1.5T, Model Number: 781145; - 2025-03-24 · US FDA — Medical DevicesClass II
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure - 2025-03-24 · US FDA — Medical DevicesClass II
Intera 1.5T Omni/Stellar, Model Number: 781104; - 2025-03-24 · US FDA — Medical DevicesClass II
Intera 0.5T Standard, Model Number: 781101; - 2025-03-24 · US FDA — Medical DevicesClass II
Intera 3.0T Quasar Dual, Model Number: 781150; - 2025-03-24 · US FDA — Medical DevicesClass II
Intera 1.5T Power/Pulsar, Model Number: 781105; - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000 - 2025-03-20 · US FDA — Medical DevicesClass II
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. - 2025-03-20 · US FDA — Medical DevicesClass II
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended len - 2025-03-18 · US FDA — Medical DevicesClass II
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software v - 2025-03-18 · US FDA — Medical DevicesClass II
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), D - 2025-03-18 · US FDA — Medical DevicesClass II
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690 - 2025-03-18 · US FDA — Medical DevicesClass II
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software v - 2025-03-18 · US FDA — Medical DevicesClass II
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E221 - 2025-03-18 · US FDA — Medical DevicesClass II
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language) - 2025-03-18 · US FDA — Medical DevicesClass II
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software v - 2025-03-13 · US FDA — Medical DevicesClass I
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with Hear - 2025-03-11 · US FDA — Medical DevicesClass II
BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispen - 2025-03-11 · US FDA — Medical DevicesClass II
BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 - 2025-03-05 · US FDA — Medical DevicesClass II
stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Inst - 2025-03-05 · US FDA — Medical DevicesClass II
stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality I - 2025-03-05 · US FDA — Medical DevicesClass II
stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty - 2025-03-05 · US FDA — Medical DevicesClass II
stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty - 2025-03-05 · US FDA — Medical DevicesClass II
stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument - 2025-03-04 · US FDA — Medical DevicesClass II
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA - 2025-03-03 · US FDA — Medical DevicesClass II
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model No - 2025-03-03 · US FDA — Medical DevicesClass II
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754 - 2025-02-27 · US FDA — Medical DevicesClass I
t:slim X2 Insulin Pump with Interoperable Technology - 2025-02-27 · US FDA — Medical DevicesClass II
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850 - 2025-02-26 · US FDA — Medical DevicesClass I
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R - 2025-02-24 · US FDA — Medical DevicesClass II
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 - 2025-02-24 · US FDA — Medical DevicesClass II
Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model - 2025-02-20 · US FDA — Medical DevicesClass II
IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouche - 2025-02-19 · US FDA — Medical DevicesClass II
GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; - 2025-02-19 · US FDA — Medical DevicesClass II
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated ca - 2025-02-19 · US FDA — Medical DevicesClass II
VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 1 - 2025-02-19 · US FDA — Medical DevicesClass II
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12 - 2025-02-19 · US FDA — Medical DevicesClass II
VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrate - 2025-02-19 · US FDA — Medical DevicesClass II
GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; - 2025-02-19 · US FDA — Medical DevicesClass II
GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2 - 2025-02-19 · US FDA — Medical DevicesClass II
Lazervida 10W diode laser cutter and engraver with Lazervida shield. - 2025-02-18 · US FDA — Medical DevicesClass II
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed - 2025-02-18 · US FDA — Medical DevicesClass II
GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed - 2025-02-18 · US FDA — Medical DevicesClass II
GE Healthcare Revolution CT, System, X-ray, Tomography, Computed - 2025-02-17 · US FDA — Medical DevicesClass II
Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediat - 2025-02-17 · US FDA — Medical DevicesClass II
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated - 2025-02-17 · US FDA — Medical DevicesClass II
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Se - 2025-02-17 · US FDA — Medical DevicesClass II
Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampli - 2025-02-17 · US FDA — Medical DevicesClass II
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated - 2025-02-17 · US FDA — Medical DevicesClass II
Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - - 2025-02-17 · US FDA — Medical DevicesClass II
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Ad - 2025-02-17 · US FDA — Medical DevicesClass II
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intub - 2025-02-17 · US FDA — Medical DevicesClass II
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediat - 2025-02-14 · US FDA — Medical DevicesClass II
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100 - 2025-02-14 · US FDA — Medical DevicesClass II
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214 - 2025-02-05 · US FDA — Medical DevicesClass I
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: - 2025-02-03 · US FDA — Medical DevicesClass II
Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, - 2025-02-03 · US FDA — Medical DevicesClass II
HemosIL LMW Heparin Controls; Part Number: 0020300200; - 2025-01-31 · US FDA — Medical DevicesClass II
Brivo MR355, NMRI system - 2025-01-31 · US FDA — Medical DevicesClass II
MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892) - 2025-01-31 · US FDA — Medical DevicesClass II
SIGNA Creator, SIGNA Explorer, NMRI systems - 2025-01-31 · US FDA — Medical DevicesClass II
MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755) - 2025-01-31 · US FDA — Medical DevicesClass II
SIGNA MR355, SIGNA MR360, NMRI system - 2025-01-31 · US FDA — Medical DevicesClass II
MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) - 2025-01-31 · US FDA — Medical DevicesClass II
Paradigm REF: MMT-712 and MMT-715 - 2025-01-31 · US FDA — Medical DevicesClass II
MiniMed insulin pump, REF: 620G (MMT-1750) - 2025-01-31 · US FDA — Medical DevicesClass II
Paradigm insulin pump, REF: MMT-754 - 2025-01-31 · US FDA — Medical DevicesClass II
MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752) - 2025-01-31 · US FDA — Medical DevicesClass II
Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751 - 2025-01-30 · US FDA — Medical DevicesClass I
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-3 - 2025-01-30 · US FDA — Medical DevicesClass I
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-3 - 2025-01-29 · US FDA — Medical DevicesClass II
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral device - 2025-01-29 · US FDA — Medical DevicesClass II
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic - 2025-01-28 · US FDA — Medical DevicesClass II
Optima XR646 HD. X-Ray imaging system. - 2025-01-28 · US FDA — Medical DevicesClass II
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system. - 2025-01-28 · US FDA — Medical DevicesClass II
Discovery XR656 HD. X-Ray imaging system. - 2025-01-27 · US FDA — Medical DevicesClass II
ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthet - 2025-01-27 · US FDA — Medical DevicesClass II
Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implan - 2025-01-27 · US FDA — Medical DevicesClass II
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001 - 2025-01-27 · US FDA — Medical DevicesClass II
Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001 - 2025-01-27 · US FDA — Medical DevicesClass II
ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthet - 2025-01-27 · US FDA — Medical DevicesClass II
ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthet - 2025-01-27 · US FDA — Medical DevicesClass II
ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prostheti - 2025-01-20 · US FDA — Medical DevicesClass II
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic - 2025-01-20 · US FDA — Medical DevicesClass II
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagn - 2025-01-16 · US FDA — Medical DevicesClass II
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0 - 2025-01-16 · US FDA — Medical DevicesClass II
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.