Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Steris Corporation
Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Steril...
Medical Devices·55 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·4 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·39 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·1 affected·Jun 15, 2017
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is in...
Medical Devices·3 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Ster...
Medical Devices·32 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterili...
Medical Devices·19 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per case Product Usage: The Vis-U-All High Temperature Steril...
Medical Devices·9 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·8 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Steril...
Medical Devices·50 affected·Jun 15, 2017
High RiskFDA
Biosense Webster, Inc.
SMARTABLATE RF System Generator
Medical Devices·185 affected·Jun 14, 2017
High RiskFDA
Becton Dickinson & Company
BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general ...
Medical Devices·1,249,200 affected·Jun 13, 2017
High RiskFDA
Merge Healthcare, Inc.
Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integratio...
Medical Devices·18 affected·Jun 13, 2017
High RiskFDA
Arrow International Inc
Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
Medical Devices·9,037 affected·Jun 12, 2017
High RiskFDA
Carefusion 303, Inc.
Alaris Pump Module model 8100
Medical Devices·35,940 affected·Jun 12, 2017
High RiskFDA
Arrow International Inc
Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
Medical Devices·9,037 affected·Jun 12, 2017
High RiskFDA
Zimmer Biomet, Inc.
DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
Medical Devices·1,524 affected·Jun 12, 2017
High RiskFDA
Invuity, Inc.
INVUITY(R) PhotonBlade(TM), REF PB1
Medical Devices·1,328 affected·Jun 12, 2017
CriticalFDA
Penumbra Inc.
Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary ...
Medical Devices·155 affected·Jun 9, 2017
High RiskFDA
Sorin Group Usa, Inc.
Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for us...
Medical Devices·105,770 affected·Jun 9, 2017
High RiskFDA
Natus Neurology Inc
Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal ...
Medical Devices·2,335 affected·Jun 9, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to pro...
Medical Devices·64 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-...
Medical Devices·1,890 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended ...
Medical Devices·145 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
CriticalFDA
Cenorin, Llc
ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices
Medical Devices·43 affected·Jun 7, 2017
High RiskFDA
Mako Surgical Corporation
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial bou...
Medical Devices·20 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-se...
Medical Devices·1,890 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
Medical Devices·5,992 affected·Jun 7, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cr...
Medical Devices·1,890 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
CriticalFDA
Cenorin, Llc
ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical d...
Medical Devices·18 affected·Jun 7, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-s...
Medical Devices·1,890 affected·Jun 7, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7...
Medical Devices·0 affected·Jun 6, 2017
High RiskFDA
Microbiologics Inc
Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets ea...
Medical Devices·8 affected·Jun 6, 2017
High RiskFDA
Microbiologics Inc
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
Medical Devices·1 affected·Jun 6, 2017
High RiskFDA
Zimmer Biomet, Inc.
RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817
Medical Devices·0 affected·Jun 5, 2017
High RiskFDA
Zimmer Biomet, Inc.
CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
Medical Devices·0 affected·Jun 5, 2017
High RiskFDA
Angiodynamics, Inc.
Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN) H787900602US0, STERILE --- This is only for use with...
Medical Devices·14,353 affected·Jun 5, 2017