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Medtest Holdings, Inc. - Pointe Scientific Chemistry Controls Level I and II - Class 3 Recall
Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2017 Category: Medical Devices Source Type: alerts

Cardiovascular Systems Inc - CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump - Class 2 Recall
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 21, 2017 Category: Medical Devices Source Type: alerts

Bard Access Systems Inc. - StatLock IV Premium Catheter Stabilization Device - Class 2 Recall
StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 20, 2017 Category: Medical Devices Source Type: alerts

Medtronic Inc., Cardiac Rhythm and Heart Failure - Amplia MRI Quad CRT0 SureScanClaria MRI Quad CRTD SureScanCompia MRI Quad CRTD SureScan - Class 2 Recall
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 20, 2017 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - NexGen Offset Stem Extension - Class 2 Recall
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 19, 2017 Category: Medical Devices Source Type: alerts

Sorin Group Italia SRL - CRF - OVATIO - Class 2 Recall
OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). OVATIO CRT 6750, PARADYM CRT-D 8750, PARADYM SonR 8770,...
Source: Medical Device Recalls - May 19, 2017 Category: Medical Devices Source Type: alerts

Sorin Group Italia SRL - CRF - PARADYM - Class 2 Recall
PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF SonR 9770 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycar...
Source: Medical Device Recalls - May 19, 2017 Category: Medical Devices Source Type: alerts

Sorin Group Italia SRL - CRF - INTENSIA - Class 2 Recall
INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). OVATIO CRT 6750, PARADYM CRT-D 8750, PARADYM SonR 8770, ...
Source: Medical Device Recalls - May 19, 2017 Category: Medical Devices Source Type: alerts

Medtest Holdings, Inc. - Pointe Scientific Hitachi AST Reagent - Class 3 Recall
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 19, 2017 Category: Medical Devices Source Type: alerts

Respironics California Inc - Philips V60 Ventilators - Class 1 Recall
Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441, 989805616411, 989805636631. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 19, 2017 Category: Medical Devices Source Type: alerts

Magellan Diagnostics, Inc. - The LeadCare Ultra Blood Lead Testing System - Class 1 Recall
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 19, 2017 Category: Medical Devices Source Type: alerts

Magellan Diagnostics, Inc. - LeadCare Plus Blood Lead Testing System - Class 1 Recall
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 19, 2017 Category: Medical Devices Source Type: alerts

Medical Action Industries Inc - Blue OR Towels - Class 2 Recall
Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Towels per/pk; (20pk/Cs). Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 18, 2017 Category: Medical Devices Source Type: alerts

Teleflex Medical - WECK Visistat 35R Disposable Skin Stapler - Class 2 Recall
WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 18, 2017 Category: Medical Devices Source Type: alerts

Medical Action Industries Inc - White OR Towels - Class 2 Recall
White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 18, 2017 Category: Medical Devices Source Type: alerts

MEDLINE INDUSTRIES INC - Medline Anterior Cervical Distraction Pin - Class 2 Recall
16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 18, 2017 Category: Medical Devices Source Type: alerts

MEDLINE INDUSTRIES INC - Medline Anterior Cervical Distraction Pin - Class 2 Recall
16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 18, 2017 Category: Medical Devices Source Type: alerts

MEDLINE INDUSTRIES INC - Medline Anterior Cervical Distraction Pin - Class 2 Recall
10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 18, 2017 Category: Medical Devices Source Type: alerts

MEDLINE INDUSTRIES INC - Medline Anterior Cervical Distraction Pin - Class 2 Recall
12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 18, 2017 Category: Medical Devices Source Type: alerts

MEDLINE INDUSTRIES INC - Medline Anterior Cervical Distraction Pin - Class 2 Recall
14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 18, 2017 Category: Medical Devices Source Type: alerts

Ziehm Imaging Inc - Ziehm Solo FD - Class 2 Recall
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 18, 2017 Category: Medical Devices Source Type: alerts

Bausch & Lomb Surgical, Inc. - SoftPort EasyLoad Lens Delivery System - Class 2 Recall
SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic puller. It is a sterile, disposable plastic device designed for single use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 17, 2017 Category: Medical Devices Source Type: alerts

Del Mar Reynolds Medical, Ltd. - Arkon Anesthesia Delivery System - Class 2 Recall
Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 17, 2017 Category: Medical Devices Source Type: alerts

Luminex Corporation - ARIES System - Class 2 Recall
ARIES System and ARIES M1 System (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 17, 2017 Category: Medical Devices Source Type: alerts

Mobius Medical Systems, LP - Mobius 3D - Class 2 Recall
Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 17, 2017 Category: Medical Devices Source Type: alerts

Abbott Medical Optics Inc. (AMO) - AMO Vitrectomy Cutter - Class 2 Recall
AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 17, 2017 Category: Medical Devices Source Type: alerts

Zimmer Gmbh - Normed General Instruments - Class 2 Recall
Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to bones/tissues for different Foot, Ankle and Hand implant systems. The instrument is used in several Normed implant systems. The instrument is used to avoid soft tissue irritation (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2017 Category: Medical Devices Source Type: alerts

Beckman Coulter Inc. - Access BR Monitor - Class 2 Recall
Access BR Monitor, Part No. 387620 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Beckman Coulter Inc. - Synchron Systems HDL Cholesterol Reagent - Class 2 Recall
HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Beckman Coulter Inc. - Synchron Systems Triglycerides Reagent - Class 2 Recall
Triglycerides Reagent (TG 2 x 300), Catalog No. 445850. Intended for quantitative determination of triglycerides concentration in human serum or plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Beckman Coulter Inc. - Synchron Systems Lactate Reagent - Class 2 Recall
Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF). (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Beckman Coulter Inc. - Synchron Systems Enzymatic Creatinine Reagent - Class 2 Recall
Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Biomet Microfixation, LLC - Biomet Microfixation TraumaOne System Surgical Tray - Class 2 Recall
Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Eden Spine Europe SA - GIZA Vertebral Body Replacement - Class 2 Recall
GIZA Vertebral Body Replacement (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Beckman Coulter Inc. - Synchron Systems Uric Acid Reagent - Class 2 Recall
Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the quantitative determination of uric acid concentration in human serum, plasma or urine. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Beckman Coulter Inc. - Synchron Systems Cholesterol Reagent - Class 2 Recall
Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Beckman Coulter Inc. - Synchron Systems Salicylate Reagent - Class 2 Recall
Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Orthosoft, Inc. dba Zimmer CAS - Navitrack System OS Knee Universal, Stereotaxic instrument - Class 2 Recall
Navitrack System - OS Knee Universal, Stereotaxic instrument (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Ortho-Clinical Diagnostics - enGen (TM) Laboratory Automation Systems - Class 2 Recall
enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC Trek RX Coronary Dilatation Catheter - Class 1 Recall
NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 1012450-15, 1012450-20, 1012451-06, 1012451-08, 1012451-12, 1012451-15, 1012451-20, 1012451-25, 1012452-08, 1012452-12, 1012452-15, 1012452-20, 1012453-08, 1012453-12, 1012453-15, 1012453-20 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC Trek RX Coronary Dilatation Catheter - Class 1 Recall
NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-12, 1013157-15 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Abbott Vascular - NC Trek RX Coronary Dilatation Catheter - Class 1 Recall
NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Hitachi Medical Systems America Inc - Arietta70 Ultrasound System - Class 2 Recall
Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Orthosoft, Inc. dba Zimmer CAS - Navitrack System OS Knee Universal - Class 3 Recall
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts

Mentor Texas, LP. - SalineFilled SPECTRUM Breast Implants - Class 2 Recall
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 12, 2017 Category: Medical Devices Source Type: alerts

Stryker Medical Division of Stryker Corporation - MediTherm Hyper/Hypothermia System, MTA7900 - Class 2 Recall
Medi-Therm Hyper/Hypothermia System, MTA7900 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2017 Category: Medical Devices Source Type: alerts

Zimmer Trabecular Metal Technology, Inc. - Zimmer Biomet Spine - Class 3 Recall
The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the propo...
Source: Medical Device Recalls - May 11, 2017 Category: Medical Devices Source Type: alerts

Abbott Medical Optics Inc. (AMO) - Healon Duet - Class 2 Recall
Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2017 Category: Medical Devices Source Type: alerts

Abbott Medical Optics Inc. (AMO) - Healon Pro - Class 2 Recall
Healon Pro, Part No. 10270012 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2017 Category: Medical Devices Source Type: alerts

Abbott Medical Optics Inc. (AMO) - Healon GV - Class 2 Recall
Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2017 Category: Medical Devices Source Type: alerts