Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM MODEL Number:M0035452530 Neurology: Target Detachable Coils are intended ...
Medical Devices·45,302 affected·Jun 6, 2016
High RiskFDA
Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020 Neurology: Target Detachable Coils are intended ...
Medical Devices·45,302 affected·Jun 6, 2016
High RiskFDA
Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M0035452020 Neurology: Target Detachable Coils are intended ...
Medical Devices·45,302 affected·Jun 6, 2016
High RiskFDA
Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: Target Detachable Coils are intended to en...
Medical Devices·45,302 affected·Jun 6, 2016
High RiskFDA
Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510 Neurology: Target Detachable Coils are intended ...
Medical Devices·45,302 affected·Jun 6, 2016
High RiskFDA
Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 Neurology: Target Detachable Coils are intended to end...
Medical Devices·45,302 affected·Jun 6, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022,...
Medical Devices·1,864 affected·Jun 3, 2016
RecallFDA
Becton Dickinson & Co.
PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the...
Medical Devices·94 affected·Jun 1, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain
Medical Devices·72 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain
Medical Devices·94 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
Medical Devices·5 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain
Medical Devices·18 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain
Medical Devices·19 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain
Medical Devices·17 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Medical Devices·25 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain
Medical Devices·9 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Medical Devices·79 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Medical Devices·60 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain
Medical Devices·27 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
Medical Devices·11 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Medical Devices·11 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain
Medical Devices·43 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain
Medical Devices·10 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain
Medical Devices·40 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain
Medical Devices·7 affected·May 27, 2016
High RiskFDA
Exactech, Inc.
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicate...
Medical Devices·8 affected·May 26, 2016
High RiskFDA
Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rhe...
Medical Devices·10 affected·May 26, 2016
High RiskFDA
Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 The LEGION Hinge Knee System is indicated for: 1. R...
Medical Devices·33 affected·May 26, 2016
High RiskFDA
Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. R...
Medical Devices·12 affected·May 26, 2016
High RiskFDA
Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is indicated for: 1. ...
Medical Devices·3 affected·May 26, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·60 affected·May 25, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
Medical Devices·424 affected·May 25, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView XCT Upgrade Model 882454
Medical Devices·3 affected·May 25, 2016
High RiskFDA
Hardy Diagnostics
QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the p...
Medical Devices·25 affected·May 24, 2016
High RiskFDA
Northridge Tri-modality Imaging,
TriFoillmaging Triumph/Triumph II Research CT scanners.
Medical Devices·3 affected·May 24, 2016
High RiskFDA
Alcon Research, Ltd.
CENTURION Vision System
Medical Devices·1 affected·May 24, 2016
High RiskFDA
Synthes (usa) Products Llc
TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single Vector Distractor and Proximal Foot Plates are ...
Medical Devices·599 affected·May 23, 2016
High RiskFDA
Synthes (usa) Products Llc
TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 The Titanium Single Vector Distractor and Proximal Foot Plate...
Medical Devices·182 affected·May 23, 2016
High RiskFDA
Synthes (usa) Products Llc
TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium Single Vector Distractor and Proximal Foot Plat...
Medical Devices·90 affected·May 23, 2016
High RiskFDA
Synthes (usa) Products Llc
TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Distractor and Proximal Foot Plates are...
Medical Devices·274 affected·May 23, 2016
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba Kalare DREX-KL80 X-ray generator
Medical Devices·254 affected·May 19, 2016
High RiskFDA
Richard Wolf Medical Instruments Corp.
Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecol...
Medical Devices·8,378 affected·May 19, 2016
High RiskFDA
Us Endoscopy Group Inc
Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to...
Medical Devices·36 affected·May 18, 2016
High RiskFDA
X Spine Systems Inc
Calix T PEEK Lumbar System, TLIF Trial
Medical Devices·1,186 affected·May 17, 2016
High RiskFDA
X Spine Systems Inc
Calix P PEEK Lumbar System, PLIF Trial
Medical Devices·1,504 affected·May 17, 2016
High RiskFDA
Lifeline First Aid Llc
5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.
Medical Devices·2,975 affected·May 16, 2016
High RiskFDA
Lifeline First Aid Llc
Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 8451740...
Medical Devices·3,572 affected·May 16, 2016
High RiskFDA
Elekta, Inc.
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Medical Devices·20 affected·May 12, 2016