Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 225 of 548
FDA Devices Moderate Mar 18, 2020
RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
RAYSEARCH LABORATORIES AB
FDA Devices Critical Mar 11, 2020
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
CareFusion 303, Inc.
FDA Devices Moderate Mar 11, 2020
Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems
Normand-Info S.A.S.U.
FDA Devices Moderate Mar 11, 2020
RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Cathet…
RESPIRATORY THERAPEUTICS GROUP LLC
FDA Devices Moderate Mar 11, 2020
Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Ster…
Bard Peripheral Vascular Inc
FDA Devices Moderate Mar 11, 2020
Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
Invivo Corporation
FDA Devices Moderate Mar 11, 2020
Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distribution. Kits…
Covidien Llc
FDA Devices Moderate Mar 11, 2020
Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228
Beckman Coulter Inc
FDA Devices Critical Mar 11, 2020
CareFusion Alaris PCA Module, Model 8120
CareFusion 303, Inc.
FDA Devices Moderate Mar 11, 2020
Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
Beckman Coulter Inc
FDA Devices Moderate Mar 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14
Deroyal Industries, Inc. Lafollette
FDA Devices Moderate Mar 11, 2020
Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for t…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Mar 11, 2020
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Baxter Healthcare Corporation
FDA Devices Low Mar 11, 2020
SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE …
Advanced Bionics, LLC
FDA Devices Moderate Mar 11, 2020
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
Roche Diagnostics Operations, Inc.
FDA Devices Critical Mar 11, 2020
CareFusion Alaris Pump Module, Model 8100
CareFusion 303, Inc.
FDA Devices Moderate Mar 11, 2020
bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated a…
Vyaire Medical
FDA Devices Moderate Mar 11, 2020
Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009
Seca
FDA Devices Moderate Mar 11, 2020
Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
Beckman Coulter Inc
FDA Devices Moderate Mar 11, 2020
Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: The system is…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Mar 11, 2020
LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion…
Organ Recovery Systems, Inc.
FDA Devices Moderate Mar 11, 2020
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
Tosoh Bioscience Inc
FDA Devices Low Mar 11, 2020
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
Biofire Defense
FDA Devices Critical Mar 11, 2020
CareFusion Alaris Syringe Module, Model 8110
CareFusion 303, Inc.
FDA Devices Moderate Mar 11, 2020
PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measur…
Polymer Technology Systems, Inc.
FDA Devices Moderate Mar 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
Deroyal Industries, Inc. Lafollette
FDA Devices Moderate Mar 11, 2020
Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro Diagnosti…
Beckman Coulter Inc
FDA Devices Moderate Mar 11, 2020
McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Ind…
Medtronic, PLC
FDA Devices Moderate Mar 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
Deroyal Industries, Inc. Lafollette
FDA Devices Moderate Mar 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
Deroyal Industries, Inc. Lafollette
FDA Devices Moderate Mar 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15
Deroyal Industries, Inc. Lafollette
FDA Devices Moderate Mar 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16
Deroyal Industries, Inc. Lafollette
FDA Devices Moderate Mar 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
Deroyal Industries, Inc. Lafollette
FDA Food Low Mar 4, 2020
Paleonola Grain Free Granola; Pumpkin Pie; packaged in 10oz stand-up pouches; UPC 013964497137
Paleonola Llc
FDA Devices Moderate Mar 4, 2020
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2H…
Microvention, Inc.
FDA Devices Moderate Mar 4, 2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353
Biomet 3i, LLC
FDA Devices Moderate Mar 4, 2020
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, 180820CC-V, …
Microvention, Inc.
FDA Devices Moderate Mar 4, 2020
THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-45…
Zimmer Biomet, Inc.
FDA Devices Moderate Mar 4, 2020
Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Se…
Philips North America, LLC
FDA Devices Moderate Mar 4, 2020
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
Medline Industries Inc
FDA Devices Moderate Mar 4, 2020
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V, 100408CMSR…
Microvention, Inc.
FDA Devices Moderate Mar 4, 2020
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204HC-S-V, 18020…
Microvention, Inc.
FDA Devices Moderate Mar 4, 2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466
Biomet 3i, LLC
FDA Devices Moderate Mar 4, 2020
MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181…
Microvention, Inc.
FDA Devices Moderate Mar 4, 2020
Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Hologic, Inc.
FDA Devices Moderate Mar 4, 2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444
Biomet 3i, LLC
FDA Devices Moderate Mar 4, 2020
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilator…
Breas Medical, Inc.
FDA Devices Moderate Mar 4, 2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566
Biomet 3i, LLC
FDA Devices Low Mar 4, 2020
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments,…
Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Mar 4, 2020
Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (…
Zimmer Surgical Inc