Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX.
Medical Devices·920 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.
Medical Devices·306 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.
Medical Devices·665 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX.
Medical Devices·895 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.
Medical Devices·311 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.
Medical Devices·333 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.
Medical Devices·411 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.
Medical Devices·575 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.
Medical Devices·656 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.
Medical Devices·520 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.
Medical Devices·547 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.
Medical Devices·678 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.
Medical Devices·640 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.
Medical Devices·733 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.
Medical Devices·527 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.
Medical Devices·198 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX.
Medical Devices·386 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX.
Medical Devices·573 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.
Medical Devices·109 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX.
Medical Devices·537 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.
Medical Devices·114 affected·Sep 19, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Sy...
Medical Devices·16 affected·Sep 18, 2017
High RiskFDA
Microport Orthopedics Inc.
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated f...
Medical Devices·48 affected·Sep 18, 2017
High RiskFDA
Encore Medical, Lp
EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from...
Medical Devices·46 affected·Sep 15, 2017
High RiskFDA
Hill-rom Manufacturing, Inc.
Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability...
Medical Devices·60 affected·Sep 15, 2017
High RiskFDA
Zimmer Biomet, Inc.
36MM COCR MODULAR HD -6MM
Medical Devices·23 affected·Sep 15, 2017
High RiskFDA
Encore Medical, Lp
EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured ...
Medical Devices·48 affected·Sep 15, 2017
High RiskFDA
Cardiovascular Systems Inc
Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive ...
Medical Devices·8 affected·Sep 14, 2017
High RiskFDA
Cardiovascular Systems Inc
Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive ...
Medical Devices·8 affected·Sep 14, 2017
High RiskFDA
Zimmer Biomet, Inc.
14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument
Medical Devices·337 affected·Sep 13, 2017
High RiskFDA
Zimmer Biomet, Inc.
979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
Medical Devices·337 affected·Sep 13, 2017
High RiskFDA
The Metrix Company
SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,
Medical Devices·50 affected·Sep 13, 2017
High RiskFDA
Otto Bock Healthcare Product
OTTO BOCK Kenevo knee joints Model 3C60=ST
Medical Devices·4 affected·Sep 12, 2017
High RiskFDA
Otto Bock Healthcare Product
OTTO BOCK Kenevo knee joints Model 3C60
Medical Devices·75 affected·Sep 12, 2017
High RiskFDA
Medtronic Inc.
Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
Medical Devices·5,842 affected·Sep 10, 2017
High RiskFDA
Handicare Usa Inc
PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Medical Devices·8 affected·Sep 8, 2017
High RiskFDA
Sysmex America, Inc.
Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sys...
Medical Devices·23,239 affected·Sep 8, 2017
High RiskFDA
Radiometer America Inc
AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules a...
Medical Devices·1,669 affected·Sep 7, 2017
High RiskFDA
Biosense Webster, Inc.
THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
Medical Devices·357 affected·Sep 6, 2017
High RiskFDA
Aesculap Implant Systems Llc
ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING ...
Medical Devices·6,211 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
Medical Devices·106,000 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿
Medical Devices·11,508 affected·Sep 5, 2017
High RiskFDA
Aesculap Implant Systems Llc
ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING ROSEN BURR TC D...
Medical Devices·10,984 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿
Medical Devices·235,560 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿
Medical Devices·128,000 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿
Medical Devices·16,380 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿
Medical Devices·102,000 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Portex Unit Dose 15 ml Normal Saline ¿
Medical Devices·357,552 affected·Sep 5, 2017