FDA Device · 2023
FDA Device recalls in 2023
RecallRadar indexes 2,477 FDA Device recall notices published in 2023. By classification: 495 Class I, 1,959 Class II, 23 Class III.
- Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723,…
FDA Device · Class I · 2023-12-27 · Nurse Assist - RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determi…
FDA Device · Class II · 2023-12-27 · Siemens Healthcare Diagnostics - Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytic…
FDA Device · Class II · 2023-12-27 · Inpeco - Injection Needle, REF: 25207
FDA Device · Class II · 2023-12-27 · Karl Storz Endoscopy - Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
FDA Device · Class II · 2023-12-27 · Exactech - Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-35…
FDA Device · Class II · 2023-12-27 · Exactech - AcuMatch Hip System, Catalog Number 142-32-27
FDA Device · Class II · 2023-12-27 · Exactech - RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determi…
FDA Device · Class II · 2023-12-27 · Siemens Healthcare Diagnostics - Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
FDA Device · Class II · 2023-12-27 · Biomet - 0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240
FDA Device · Class I · 2023-12-27 · Nurse Assist - Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010…
FDA Device · Class II · 2023-12-27 · Philips Medical Systems Nederland B V - Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005
FDA Device · Class I · 2023-12-27 · Nurse Assist - ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabili…
FDA Device · Class II · 2023-12-27 · Olympus - Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03
FDA Device · Class II · 2023-12-27 · Exactech - Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g)…
FDA Device · Class II · 2023-12-27 · Exactech - Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
FDA Device · Class II · 2023-12-27 · Exactech - Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
FDA Device · Class II · 2023-12-27 · Maquet Medical Systems Usa - AirFit N10 Nasal Masks and User Guide
FDA Device · Class I · 2023-12-27 · Resmed - Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38…
FDA Device · Class II · 2023-12-27 · Exactech - AirFit F30 Full Face Mask and User Guide
FDA Device · Class I · 2023-12-27 · Resmed - Injection Needle, LUER-lock,0.8mm, REF: 26175PD
FDA Device · Class II · 2023-12-27 · Karl Storz Endoscopy - Injection Needle, 3 Fr., REF: 27030N
FDA Device · Class II · 2023-12-27 · Karl Storz Endoscopy - Injection Needle, single cvd. 70 degrees, REF: 738750
FDA Device · Class II · 2023-12-27 · Karl Storz Endoscopy - CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
FDA Device · Class II · 2023-12-27 · Cardioquip - RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determ…
FDA Device · Class II · 2023-12-27 · Siemens Healthcare Diagnostics - epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 1…
FDA Device · Class II · 2023-12-27 · Siemens Healthcare Diagnostics - ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
FDA Device · Class II · 2023-12-27 · Zeus Scientific - RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determi…
FDA Device · Class II · 2023-12-27 · Siemens Healthcare Diagnostics - The device is a whole-body CT x-ray system
FDA Device · Class II · 2023-12-27 · Philips North America - AirFit N20 Nasal Mask and User Guide
FDA Device · Class I · 2023-12-27 · Resmed - Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE SALINE BOTTLE/1022,…
FDA Device · Class I · 2023-12-27 · Nurse Assist - Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-…
FDA Device · Class II · 2023-12-27 · Exactech - AirFit F30i Full Face Mask and User Guide
FDA Device · Class I · 2023-12-27 · Resmed - AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
FDA Device · Class II · 2023-12-27 · Physio Control - Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
FDA Device · Class I · 2023-12-27 · Fresenius Kabi Usa - AirTouch N20 Nasal Mask and User Guide
FDA Device · Class I · 2023-12-27 · Resmed - Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
FDA Device · Class II · 2023-12-27 · Exactech - Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01
FDA Device · Class II · 2023-12-27 · Abbott Laboratories - Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
FDA Device · Class II · 2023-12-27 · Biomet - ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
FDA Device · Class II · 2023-12-27 · Zeus Scientific - Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
FDA Device · Class II · 2023-12-27 · Maquet Cardiovascular - Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-0035, d) 02-023-02-0038, e) 0…
FDA Device · Class II · 2023-12-27 · Exactech - Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
FDA Device · Class II · 2023-12-27 · Exactech - Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion…
FDA Device · Class II · 2023-12-27 · Philips Medical Systems Nederland B V - LITe Decompression Snake Arm, REF 48080230
FDA Device · Class II · 2023-12-27 · Stryker Spine - CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
FDA Device · Class II · 2023-12-27 · Cardioquip - AirFit F20 Full Face Mask and User Guide
FDA Device · Class I · 2023-12-27 · Resmed - Injection Needle, curved 23 cm, REF: 8598A
FDA Device · Class II · 2023-12-27 · Karl Storz Endoscopy - CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal b…
FDA Device · Class III · 2023-12-27 · Maquet Medical Systems Usa - VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01
FDA Device · Class II · 2023-12-27 · Vero Biotech - Exactech Novation Hip System, Catalog Numbers: 134-36-45
FDA Device · Class II · 2023-12-27 · Exactech - AirTouch F20 Full Face Mask and User Guide
FDA Device · Class I · 2023-12-27 · Resmed - 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210
FDA Device · Class I · 2023-12-27 · Nurse Assist - CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 8…
FDA Device · Class I · 2023-12-20 · Integra Lifesciences - RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204
FDA Device · Class II · 2023-12-20 · Encore Medical - STERILE PVP SOLUTION, REF DYNDA1907
FDA Device · Class II · 2023-12-20 · Medline Industries Northfield - Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-…
FDA Device · Class II · 2023-12-20 · Riverpoint Medical - STERILE PVP SLN KIT, REF DYNDM1097
FDA Device · Class II · 2023-12-20 · Medline Industries Northfield - Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal pa…
FDA Device · Class II · 2023-12-20 · Meridian Bioscience - The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specif…
FDA Device · Class II · 2023-12-20 · Bioreference Health - Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Ca…
FDA Device · Class II · 2023-12-20 · Meridian Bioscience - STERILE STERILE PREP STICK, REF DYNDA1134
FDA Device · Class II · 2023-12-20 · Medline Industries Northfield - Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
FDA Device · Class II · 2023-12-20 · Baxter Healthcare - Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS
FDA Device · Class II · 2023-12-20 · Change Healthcare Canada - VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
FDA Device · Class II · 2023-12-20 · Ortho Clinical Diagnostics - Navik 3D v2, REF NAVIK3D, 3D Mapping System
FDA Device · Class III · 2023-12-20 · Apn Health - TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
FDA Device · Class II · 2023-12-20 · Olympus - PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
FDA Device · Class II · 2023-12-20 · Limacorporate S P A - Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens cont…
FDA Device · Class II · 2023-12-20 · Meridian Bioscience - Medtronic SynchroMed, Model A10
FDA Device · Class II · 2023-12-20 · Medtronic - Medline Leg bag, REF URO12573
FDA Device · Class II · 2023-12-20 · Medline Industries Northfield - STERILE BETADINE, REF DYNDA1998
FDA Device · Class II · 2023-12-20 · Medline Industries Northfield - STERILE PVP, REF DYNDA1649
FDA Device · Class II · 2023-12-20 · Medline Industries Northfield - Medline Leg bag, REF DYND12574
FDA Device · Class II · 2023-12-20 · Medline Industries Northfield - Sensica Urine Output System, Catalog Number SCCS1002
FDA Device · Class II · 2023-12-20 · C R Bard - Panorama 1.0T HFO, Magnetic Resonance (MR) System
FDA Device · Class I · 2023-12-20 · Philips North America - VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
FDA Device · Class II · 2023-12-20 · Ortho Clinical Diagnostics - The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table,…
FDA Device · Class II · 2023-12-20 · Ge Hangwei Medical Systems - STERILE POVIDONE, REF DYNDA2061
FDA Device · Class II · 2023-12-20 · Medline Industries Northfield - Medline Leg bag, REF DYND12578
FDA Device · Class II · 2023-12-20 · Medline Industries Northfield - VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
FDA Device · Class II · 2023-12-20 · Ortho Clinical Diagnostics - Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 42…
FDA Device · Class II · 2023-12-20 · Spectranetics - PVP SOLUTION SING STRL, REF DYNDA1858
FDA Device · Class II · 2023-12-20 · Medline Industries Northfield - SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
FDA Device · Class II · 2023-12-20 · Bebig Isotopentechnik - The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table,…
FDA Device · Class II · 2023-12-20 · Ge Hangwei Medical Systems - ARTIS icono (ceiling configuration), Fluoroscopic x-ray system
FDA Device · Class II · 2023-12-20 · Siemens Medical Solutions Usa - CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal…
FDA Device · Class II · 2023-12-20 · Maquet Medical Systems Usa - VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
FDA Device · Class II · 2023-12-20 · Ortho Clinical Diagnostics - VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
FDA Device · Class II · 2023-12-20 · Ortho Clinical Diagnostics - Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedur…
FDA Device · Class II · 2023-12-13 · Coopersurgical - ProCuity bed series, model number 3009, item number: 3009PX-L-100
FDA Device · Class II · 2023-12-13 · Stryker Medical Division - EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens
FDA Device · Class II · 2023-12-13 · Staar Surgical - Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
FDA Device · Class II · 2023-12-13 · Auris Health - HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
FDA Device · Class II · 2023-12-13 · Heartware - DRX Revolution Mobile X-Ray System
FDA Device · Class II · 2023-12-13 · Carestream Health - QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667
FDA Device · Class II · 2023-12-13 · Wilson Cook Medical - ProCuity bed series, model number 3009, item number: 3009PX-ZM-600
FDA Device · Class II · 2023-12-13 · Stryker Medical Division - Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036
FDA Device · Class II · 2023-12-13 · Atrium Medical - CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
FDA Device · Class II · 2023-12-13 · Cardioquip - QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654
FDA Device · Class II · 2023-12-13 · Wilson Cook Medical
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