Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Smith & Nephew, Inc.
D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic
Medical Devices·19 affected·Mar 9, 2017
High RiskFDA
Smith & Nephew, Inc.
D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic
Medical Devices·100 affected·Mar 9, 2017
High RiskFDA
Cincinnati Sub-zero Products Inc
Hemotherm CE, model 400CE, Heater-Cooling Device
Medical Devices·390 affected·Mar 9, 2017
High RiskFDA
Centurion Medical Products Corporation
OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then p...
Medical Devices·1,692 affected·Mar 9, 2017
High RiskFDA
Centurion Medical Products Corporation
OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then plac...
Medical Devices·588 affected·Mar 9, 2017
High RiskFDA
Ferno-washington Inc
Ferno PROFlexx¿ Model 28Z Chair Cot
Medical Devices·34 affected·Mar 8, 2017
High RiskFDA
Sonesta Medical Ab
Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V
Medical Devices·28 affected·Mar 8, 2017
High RiskFDA
Aesculap Implant Systems Llc
AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic proc...
Medical Devices·21 affected·Mar 7, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, comm...
Medical Devices·104 affected·Mar 6, 2017
High RiskFDA
Covidien Llc
Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium chloride dressing is saturated in a 2...
Medical Devices·104,688 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 1.1MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7592, STERILE, Rx Only Product Usage: The LaserEdge Knives are...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 3.2MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7557A, STERILE, Rx Only Product Usage: The LaserEdge Knives are...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, CLEAR 3.0 MM CLEAR CORNEAL ANGLED KNIFE (6/BOX), REF/PRODUCT CODE E7529, STERILE, Rx Only Product Usage: The Laser...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Covidien Llc
Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of various materials, such as gau...
Medical Devices·1,659,500 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.4 MM SLIT KNIFE ANGLED DOUBLE BEVEL, REF/PRODUCT CODE E7549ADB, STERILE, Rx Only Product Usage: The LaserEdge Kni...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7551ADB, STERILE, Rx Only Product Usage: The Lase...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, CRESCENT BLADE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510, STERILE, Rx Only Product Usage: The LaserEdge Kn...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 30 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7530T, STERILE, Rx Only Product Usage: The LaserEdge Knives ar...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL GUARDED (6/BOX), REF/PRODUCT CODE E7551ADBG, STERILE, Rx Only Product Usage: ...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 20 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7520, STERILE, Rx Only Product Usage: The LaserEdge Knives are inten...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, CRESCENT BLADE ANGLED TIP BEVEL UP (6/BOX), REF/PRODUCT CODE E7510AT, STERILE, Rx Only Product Usage: The LaserEdge ...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.8MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7552ADB, STERILE, Rx Only Product Usage: The Laser...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 15 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7515, STERILE, Rx Only Product Usage: The LaserEdge Knives are i...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Integra Lifesciences Corp.
Panta Nail, Rx only, Sterile,
Medical Devices·4,449 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.5 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7550A, STERILE, Rx Only Product Usage: The LaserEdge Knives ar...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.85MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7553A, STERILE, Rx Only Product Usage: The LaserEdge Knives ar...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7601, STERILE, Rx Only Product Usage: The LaserEdge Knives...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE E7528G, STERILE, Rx Only Product Usage: The LaserEd...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Covidien Llc
Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various materials, such as gau...
Medical Devices·7,168,000 affected·Mar 3, 2017
High RiskFDA
Verathon Inc
It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). Pa...
Medical Devices·292 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7556A, STERILE, Rx Only Product Usage: The LaserEd...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.5 MM SLIT KNIFE BEVEL UP ANGLED GUARDED(6/BOX), REF/PRODUCT CODE E7550AG, STERILE, Rx Only Product Usage: The La...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.6 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7550ADB, STERILE, Rx Only Product Usage: The Lase...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Covidien Llc
Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity sodium chloride dressing is saturated in a 20...
Medical Devices·1,222,080 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75 (6/BOX), REF/PRODUCT CODE E7527, STERILE, Rx Only Product Usage: The LaserEdge Knives ar...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, KNIFE ANGLED BEVELED UP 2.7(6/BOX), REF/PRODUCT CODE E7559A, STERILE, Rx Only Product Usage: The LaserEdge Knives ...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.85 (6/BOX), REF/PRODUCT CODE E7528, STERILE, Rx Only Product Usage: The LaserEdge Knives ar...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.9MM (6/BOX), REF/PRODUCT CODE E7587A, STERILE, Rx Only Product Usage: The LaserEdge Knives ...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 0.88MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7593, STERILE, Rx Only Product Usage: The LaserEdge Knives ar...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 30 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7530, STERILE, Rx Only Product Usage: The LaserEdge Knives are int...
Medical Devices·1,236,749 affected·Mar 3, 2017
High RiskFDA
Bausch & Lomb Inc Irb
LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED BEVEL UP GUARDED (6/BOX), REF/PRODUCT CODE E7551AG, STERILE, Rx Only Product Usage: The L...
Medical Devices·1,236,749 affected·Mar 3, 2017
RecallFDA
Microbiologics Inc
LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single mic...
Medical Devices·1 affected·Mar 2, 2017
High RiskFDA
Ortho Kinematics, Inc
Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intend...
Medical Devices·1 affected·Mar 2, 2017
High RiskFDA
Roche Diagnostics Corporation
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
Medical Devices·45 affected·Mar 1, 2017
High RiskFDA
Zimmer Biomet, Inc.
Por fullct fem st 17x200mm, Sterile,
Medical Devices·9,867 affected·Feb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Por fullct fem st 18x200mm, Sterile,
Medical Devices·9,867 affected·Feb 28, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker SmartLife Large Aseptic Housing (7126-120-000)
Medical Devices·302 affected·Feb 28, 2017
High RiskFDA
Devicor Medical Products Inc
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious u...
Medical Devices·320 affected·Feb 28, 2017