Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 159 of 548
FDA Drug Moderate Feb 2, 2022
Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr.…
Edge Pharma, LLC
FDA Drug Moderate Feb 2, 2022
Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 0544…
Edge Pharma, LLC
FDA Drug Moderate Feb 2, 2022
Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit includes; indi…
Edge Pharma, LLC
FDA Devices Critical Feb 2, 2022
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pres…
Philips Respironics, Inc.
FDA Devices Moderate Feb 2, 2022
GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
GE Healthcare, LLC
FDA Devices Moderate Feb 2, 2022
GE Vscan Extend, being sold as "Vscan Extend Dual USB"
GE Healthcare, LLC
FDA Devices Moderate Feb 2, 2022
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Feb 2, 2022
GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
GE Healthcare, LLC
FDA Devices Moderate Feb 2, 2022
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Feb 2, 2022
GE Vscan Extend, being sold as "Vscan Extend Sector USB"
GE Healthcare, LLC
FDA Devices Moderate Feb 2, 2022
GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
GE Healthcare, LLC
FDA Devices Moderate Feb 2, 2022
GE Vscan Extend, being sold as "Vscan Extend Console"
GE Healthcare, LLC
FDA Devices Moderate Feb 2, 2022
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Feb 2, 2022
API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses minia…
Biomerieux Inc
FDA Devices Moderate Feb 2, 2022
1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
NRT X-RAY A/S
FDA Devices Moderate Feb 2, 2022
8mm FlexDex Needle Driver, Product Code FD-335 ND
FlexDex Inc.
FDA Devices Moderate Feb 2, 2022
GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
GE Healthcare, LLC
FDA Devices Critical Feb 2, 2022
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent po…
Philips Respironics, Inc.
FDA Devices Moderate Feb 2, 2022
PIVO Blood Collection Device 20G, REF: 202-0005
Velano Vascular
FDA Devices Moderate Jan 26, 2022
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Philips North America Llc
FDA Devices Critical Jan 26, 2022
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) …
ev3 Inc.
FDA Devices Moderate Jan 26, 2022
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Covidien, LP
FDA Devices Moderate Jan 26, 2022
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 45…
Greiner Bio-One North America, Inc.
FDA Devices Moderate Jan 26, 2022
Senior Living Arial Emergency and Nurse Call Systems
Stanley Security Solutions Inc
FDA Devices Moderate Jan 26, 2022
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Philips North America Llc
FDA Devices Moderate Jan 26, 2022
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Draeger Medical, Inc.
FDA Devices Moderate Jan 26, 2022
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Jan 26, 2022
KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
Microbiologics Inc
FDA Devices Moderate Jan 26, 2022
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # …
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jan 26, 2022
Heel Snuggler, Reference # 989805603411 99047
Philips North America Llc
FDA Devices Moderate Jan 26, 2022
Gentueri Viral Transport Medium (VTM), Sterile, IVD
Gentueri Inc
FDA Devices Moderate Jan 26, 2022
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Straumann USA LLC
FDA Devices Moderate Jan 26, 2022
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Luminex Corporation
FDA Devices Moderate Jan 26, 2022
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Straumann USA LLC
FDA Devices Moderate Jan 26, 2022
Infant Heel Warmers w/strap, Reference # 989805603201 1223
Philips North America Llc
FDA Devices Moderate Jan 26, 2022
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
Philips North America Llc
FDA Devices Moderate Jan 26, 2022
ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagno…
Konica Minolta Healthcare Americas, Inc.
FDA Devices Critical Jan 26, 2022
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) C…
ev3 Inc.
FDA Devices Moderate Jan 26, 2022
Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 81…
Compass Health Brands (Corporate Office)
FDA Devices Moderate Jan 19, 2022
SOMATOM Edge Plus-Computed tomography system Model 1026700
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jan 19, 2022
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model B…
Medtronic Perfusion Systems
FDA Devices Moderate Jan 19, 2022
GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
DePuy Orthopaedics, Inc.
FDA Devices Moderate Jan 19, 2022
GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
DePuy Orthopaedics, Inc.
FDA Devices Moderate Jan 19, 2022
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
Technomed Europe
FDA Devices Moderate Jan 19, 2022
SOMATOM Definition AS-Computed tomography system Model 8098027
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jan 19, 2022
SOMATOM Definition Edge -Computed tomography system Model 10590000
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jan 19, 2022
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recover…
Philips North America Llc
FDA Devices Moderate Jan 19, 2022
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Gentherm Medical, LLC
FDA Devices Moderate Jan 19, 2022
Regard, T AND A - Rogers, sterilized convenience kits
ROi CPS LLC
FDA Devices Moderate Jan 19, 2022
Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement …
Ohio Medical Corporation