Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and...
Medical Devices·5 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) a...
Medical Devices·12 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (C...
Medical Devices·4 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) ...
Medical Devices·16 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and...
Medical Devices·63 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomogra...
Medical Devices·2 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Pos...
Medical Devices·83 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography...
Medical Devices·1 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomog...
Medical Devices·2 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomograp...
Medical Devices·49 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and...
Medical Devices·100 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and ...
Medical Devices·15 affected·Apr 22, 2016
High RiskFDA
Acumedia Manufacturers, Inc.
Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
Medical Devices·482 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT)...
Medical Devices·2 affected·Apr 22, 2016
High RiskFDA
Arthrex, Inc.
BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and ...
Medical Devices·138 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and...
Medical Devices·127 affected·Apr 22, 2016
High RiskFDA
Miami Fat Supply, Inc
The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissu...
Medical Devices·443 affected·Apr 21, 2016
High RiskFDA
Draeger Medical, Inc.
Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000)...
Medical Devices·16,078 affected·Apr 21, 2016
High RiskFDA
Acorn Stairlifts, Inc
Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift
Medical Devices·26,428 affected·Apr 20, 2016
High RiskFDA
Elekta, Inc.
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head struct...
Medical Devices·217 affected·Apr 19, 2016
High RiskFDA
Synthes (usa) Products Llc
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instru...
Medical Devices·7,363 affected·Apr 18, 2016
High RiskFDA
Ziehm Imaging Inc
Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
Medical Devices·1 affected·Apr 15, 2016
High RiskFDA
2k Innovations Inc.
Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps
Medical Devices·22,757 affected·Apr 15, 2016
High RiskFDA
Ziehm Imaging Inc
Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
Medical Devices·31 affected·Apr 15, 2016
High RiskFDA
2k Innovations Inc.
Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps
Medical Devices·22,757 affected·Apr 15, 2016
High RiskFDA
2k Innovations Inc.
Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wraps
Medical Devices·22,757 affected·Apr 15, 2016
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 00588605312 TM LPS TIB SZ 3 C/D, 14MM - 00588605314 TM LPS T...
Medical Devices·19,884 affected·Apr 15, 2016
High RiskFDA
Ziehm Imaging Inc
Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging
Medical Devices·14 affected·Apr 15, 2016
High RiskFDA
2k Innovations Inc.
Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps
Medical Devices·22,757 affected·Apr 15, 2016
High RiskFDA
2k Innovations Inc.
Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps
Medical Devices·22,757 affected·Apr 15, 2016
High RiskFDA
2k Innovations Inc.
Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps
Medical Devices·22,757 affected·Apr 15, 2016
High RiskFDA
2k Innovations Inc.
Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps
Medical Devices·22,757 affected·Apr 15, 2016
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606512 TM MONO TIB STR GRN SZ 5 14MM - 00588606514 TM MON...
Medical Devices·19,884 affected·Apr 15, 2016
High RiskFDA
Carestream Health Inc
CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 65...
Medical Devices·37 affected·Apr 15, 2016
High RiskFDA
Cook Inc.
FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the ut...
Medical Devices·1,881 affected·Apr 15, 2016
High RiskFDA
Ziehm Imaging Inc
Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging
Medical Devices·2 affected·Apr 15, 2016
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB SZ 3 C-H, 14MM - 00588604314 TM CR TIB...
Medical Devices·19,884 affected·Apr 15, 2016
High RiskFDA
2k Innovations Inc.
Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
Medical Devices·22,757 affected·Apr 15, 2016
High RiskFDA
B. Braun Medical, Inc.
Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inve...
Medical Devices·11,000 affected·Apr 14, 2016
High RiskFDA
Randox Laboratories, Limited
Magnesium on RX Imola analyser IVD
Medical Devices·15 affected·Apr 14, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, ...
Medical Devices·30 affected·Apr 13, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (...
Medical Devices·8 affected·Apr 13, 2016
High RiskFDA
Exactech, Inc.
Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14; For use in primary total hip ...
Medical Devices·1 affected·Apr 12, 2016
High RiskFDA
Exactech, Inc.
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total...
Medical Devices·2 affected·Apr 12, 2016
High RiskFDA
Exactech, Inc.
Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total h...
Medical Devices·1 affected·Apr 12, 2016
High RiskFDA
Echopixel, Inc.
TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health c...
Medical Devices·9 affected·Apr 11, 2016
High RiskFDA
Biomet, Inc.
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
Medical Devices·22 affected·Apr 11, 2016
High RiskFDA
Natus Medical Incorporated
Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040...
Medical Devices·13,541 affected·Apr 11, 2016