Browse recalls
Alert level: Class II
- 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 - 2025-03-11 · 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 II
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850 - 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 - 2025-02-03 · 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 - 2025-01-29 · 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. - 2025-01-16 · US FDA — Medical DevicesClass II
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1 - 2025-01-16 · US FDA — Medical DevicesClass II
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and - 2025-01-16 · US FDA — Medical DevicesClass II
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2 - 2025-01-16 · US FDA — Medical DevicesClass II
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0 - 2025-01-16 · US FDA — Medical DevicesClass II
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9. - 2025-01-16 · US FDA — Medical DevicesClass II
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0. - 2025-01-13 · US FDA — Medical DevicesClass II
Azurion 3 M12 System Code: (1) 722063 (2) 722221 - 2025-01-13 · US FDA — Medical DevicesClass II
Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235 - 2025-01-13 · US FDA — Medical DevicesClass II
Allura CV20 System Code: 722031 - 2025-01-13 · US FDA — Medical DevicesClass II
Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236 - 2025-01-13 · US FDA — Medical DevicesClass II
AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028 - 2025-01-13 · US FDA — Medical DevicesClass II
AlluraXperFD20/10 System Code: (1) 722029 - 2025-01-13 · US FDA — Medical DevicesClass II
AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013 - 2025-01-13 · US FDA — Medical DevicesClass II
Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 - 2025-01-13 · US FDA — Medical DevicesClass II
AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035 - 2025-01-13 · US FDA — Medical DevicesClass II
AlluraXperFD20/15 System Code: (1) 722058 - 2025-01-13 · US FDA — Medical DevicesClass II
Azurion 5 M12 System Code: (1) 722227 (2) 722231 - 2025-01-13 · US FDA — Medical DevicesClass II
AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027 - 2025-01-10 · US FDA — Medical DevicesClass II
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software. - 2025-01-09 · US FDA — Medical DevicesClass II
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056) - 2025-01-09 · US FDA — Medical DevicesClass II
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/C - 2025-01-08 · US FDA — Medical DevicesClass II
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 7173 - 2025-01-02 · US FDA — Medical DevicesClass II
ARTIS One Angiographic X-Ray System - 2025-01-02 · US FDA — Medical DevicesClass II
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems - 2024-12-19 · US FDA — Medical DevicesClass II
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certif - 2024-12-19 · US FDA — Medical DevicesClass II
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified - 2024-12-19 · US FDA — Medical DevicesClass II
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Cer - 2024-12-18 · US FDA — Medical DevicesClass II
GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Com - 2024-12-18 · US FDA — Medical DevicesClass II
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomogra