Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Gentell, Inc
Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated ...
Medical Devices·6,433 affected·Feb 27, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Synaptive Medical Inc
ClearCanvas RIS/PACS
Medical Devices·903 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Becton Dickinson & Company
BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277
Medical Devices·1,262 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Becton Dickinson & Company
BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000435
Medical Devices·1,262 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Capso Vision, Inc.
The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: ...
Medical Devices·82 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
Medical Devices·230 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Becton Dickinson & Company
BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000026A
Medical Devices·1,262 affected·Feb 26, 2020
High RiskFDA
Becton Dickinson & Company
BARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276
Medical Devices·1,262 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Becton Dickinson & Company
BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278
Medical Devices·1,262 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Becton Dickinson & Company
BARD MYPICC KIT 4F Dual-Lumen, Catalog Number CK000418B
Medical Devices·1,262 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
Medical Devices·230,001 affected·Feb 26, 2020
High RiskFDA
Biomet, Inc.
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total sh...
Medical Devices·21 affected·Feb 25, 2020
High RiskFDA
Acutus Medical Inc
Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
Medical Devices·30 affected·Feb 25, 2020
High RiskFDA
Livanova Usa Inc.
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm ...
Medical Devices·9,309 affected·Feb 24, 2020
High RiskFDA
Epimed International
R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The E...
Medical Devices·1,374 affected·Feb 21, 2020
High RiskFDA
Epimed International
R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Product Usage:The Ep...
Medical Devices·701 affected·Feb 21, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Medical Devices·255 affected·Feb 20, 2020
High RiskFDA
Philips North America, Llc
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.0...
Medical Devices·2,214 affected·Feb 20, 2020
High RiskFDA
Radiometer Medical Aps
TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), T...
Medical Devices·84 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Haemonetics Corporation
TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagul...
Medical Devices·88 affected·Feb 19, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 ...
Medical Devices·1,012 affected·Feb 18, 2020
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·1,644 affected·Feb 18, 2020
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·628 affected·Feb 18, 2020