Medical device recalls
39137 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-04-07FDA-DeviceAlcon Research, LLCClass IIAlcon Custom Ophthalmic Surgical Procedure Packs
Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.
- 2021-04-07FDA-DeviceStryker Sustainability SolutionsClass IIStryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing
Product was distributed without receiving regulatory clearance.
- 2021-04-07FDA-DevicePhilips North America, LLCClass IIPhilips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi"gns VM8 (863066, 863068, 863087, 863088) Model Numbers: 863063,863064,863065,863066,863068,863085,863086, 453564021961,453564021971, 53564022001,453564022041, 53564022081,453564024371, 45356402
Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of heart rate meter for pediatric mode-In pediatric mode, when the input signal rate is over 300 bpm, the indicated rate of the affected products will be lower than this upper limit
- 2021-04-07FDA-DeviceNuvasive Specialized Orthopedics IncClass IIPRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.
- 2021-04-07FDA-DeviceNuvasive Specialized Orthopedics IncClass IIPrecice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.
- 2021-04-07FDA-DeviceNuvasive Specialized Orthopedics IncClass IIPRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.
- 2021-04-07FDA-DeviceEPIX THERAPEUTICS, INCClass IIEPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 00812499030013
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
- 2021-04-07FDA-DeviceEPIX THERAPEUTICS, INCClass IIEPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
- 2021-04-07FDA-DeviceEPIX THERAPEUTICS, INCClass IIEPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
- 2021-04-07FDA-DeviceEPIX THERAPEUTICS, INCClass IIEPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB300S, SterileEO, UDI: 00812499030358
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
- 2021-04-07FDA-DeviceEPIX THERAPEUTICS, INCClass IIEPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF: CEDT200L, Sterile EO, UDI: 00812499030259
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
- 2021-04-07FDA-DeviceEPIX THERAPEUTICS, INCClass IIEPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
- 2021-04-07FDA-DeviceDePuy Orthopaedics, Inc.Class IIThe ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
- 2021-04-07FDA-DeviceDePuy Orthopaedics, Inc.Class IIThe LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
- 2021-04-07FDA-DeviceDePuy Orthopaedics, Inc.Class IIATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
- 2021-04-07FDA-DeviceMedtronic Perfusion SystemsClass IMedtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.
An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the pump stopping, the user interface going blank, and smoking and producing a burning odor during use.
- 2021-04-07FDA-DeviceLumiraDxClass IICoronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset.
Two lots of test strips failed QC testing using blank buffer due to false positives.
- 2021-04-07FDA-DeviceHollister IncorporatedClass IIVertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage: designed to stabilize and secure a variety of catheters, surgical drains, and tubes from sizes 5-40 French.
The tube holder can separate from the barrier that secures the device to the patients' body. The tube holder has the potential failure to separate from the barrier. This separation might contribute to the potential risk of the tube/drain/catheter migration or loss.
- 2021-04-07FDA-DeviceArthrex, Inc.Class IIDrill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
- 2021-04-07FDA-DeviceCareFusion 303, Inc.Class IBD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion start delay/inability to titrate medication. 2) Stuck keys: PC unit alarms, module exhibits Channel Error, may result in infusion interruption/start delay
- 2021-04-07FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IImplantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3) Amplia family: Amplia MRI CRT-D and Amplia MRI Quad CRT-D models; 4) Compia family: Compia MRI CRT-D model; 5) Brava family: Brava CRT-D and Brava Quad CRT-D models (OUS only); Implantable Cardioverter Defibrillat
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation
- 2021-04-07FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IImplantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythm
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation
- 2021-04-07FDA-DeviceSmisson-Cartledge Biomedical, LLCClass IThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
- 2021-04-07FDA-DeviceSmisson-Cartledge Biomedical, LLCClass IThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
- 2021-04-07FDA-DeviceSmisson-Cartledge Biomedical, LLCClass IThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
- 2021-03-31FDA-DeviceBiomerieux IncClass IIVITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibi
bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VITEK¿ 2 do not match the results sent to the LIS and the Laboratory Technician would need to change results in the LIS to match those in the VITEK¿ 2. If the isolate is sent more than once to LIS, a software defect prevents the system from sending the expertised interpretation results and the Therapeutic Corrections (TC) is not sent to Laboratory Information Systems (LIS).
- 2021-03-31FDA-DeviceBiomerieux IncClass IIVITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory con
bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VITEK¿ 2 do not match the results sent to the LIS and the Laboratory Technician would need to change results in the LIS to match those in the VITEK¿ 2. If the isolate is sent more than once to LIS, a software defect prevents the system from sending the expertised interpretation results and the Therapeutic Corrections (TC) is not sent to Laboratory Information Systems (LIS).
- 2021-03-31FDA-DeviceCardinal Health 200, LLCClass IIFemoral Angiography Drape Bulk Non-Sterile
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.
- 2021-03-31FDA-DeviceCardinal Health 200, LLCClass IIFemoral Angiography Drape Sterile
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.
- 2021-03-31FDA-DeviceCardinal Health 200, LLCClass IIIn-View Clear Leggings Bulk Non-Sterile
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.
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