Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 7,001–7,050 of 8,689
- Class II
Medical Device Recall · April 18, 2024
The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014in. The guStryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.
- Class II
Medical Device Recall · April 18, 2024
The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. The guidewireStryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.
- Class II
Medical Device Recall · April 18, 2024
The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0.010in. The outside diameter of the Syncrho 14 guidewire is 0.0Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.
- Class II
Medical Device Recall · April 18, 2024
OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MMExactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- Class II
Medical Device Recall · April 18, 2024
OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MMExactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- Class II
Medical Device Recall · April 18, 2024
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnosticBeckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids, by correction. The reason for the recall is: Beckman Coulter has determined that the DxI 9000 Access Immunoassay analyzer accepts calibrator values scanned from multiple calibrator cards when an operator configures a new calibrator lot. The analyzer accepts the calibrator lot values from any scanned calibrator card, regardless of the assay test code or calibrator material lot number. The software is not validating the integrity of each calibrator barcode scanned to ensure they are all from the same calibrator card. This includes all software versions and all DxI 9000 instruments that are currently in the field. This issue does not impact calibrator material with 2D calibrator card barcodes. This may cause a failed calibration curve. The health risk to patients is dependent upon the analytes that could be impacted by the error, to include receiving delayed or erroneous results. The issue was identified by Beckman Coulter while conducting a field action on DxI 9000 Access Immunoassay Analyzers.
- Class II
Medical Device Recall · April 18, 2024
MED-EL Elektromedizinische Gereate, Gmbh
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear ImplantA small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.
- Class II
Medical Device Recall · April 18, 2024
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- Class I
Medical Device Recall · April 18, 2024
OptumHealth Care Solutions LLC
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion PumpNimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing.
- Class II
Medical Device Recall · April 18, 2024
OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MMExactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- Class II
Medical Device Recall · April 18, 2024
Boston Scientific Neuromodulation Corporation
Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.
- Class II
Medical Device Recall · April 18, 2024
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentraWhen the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians.
- Class II
Medical Device Recall · April 17, 2024
Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they currently do not bear the required certification label.
- Class II
Medical Device Recall · April 17, 2024
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.The guide tip can become damaged and result in the tip detaching.
- Class II
Medical Device Recall · April 17, 2024
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Class II
Medical Device Recall · April 17, 2024
CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.Potential contamination of the product with latex adhesive residual.
- Class II
Medical Device Recall · April 17, 2024
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray systemX-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.
- Class II
Medical Device Recall · April 17, 2024
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev AAn increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Class II
Medical Device Recall · April 17, 2024
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Class II
Medical Device Recall · April 17, 2024
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HNDPotential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
- Class II
Medical Device Recall · April 17, 2024
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Class II
Medical Device Recall · April 17, 2024
MEDLINE INDUSTRIES, LP - Northfield
Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B; c) SYRINGE 20ML RED L/L LOW PRESS, IThese syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified that may pose a risk to patient health.
- Class II
Medical Device Recall · April 17, 2024
Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-VNon-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they currently do not bear the required certification label.
- Class II
Medical Device Recall · April 17, 2024
Fresenius Medical Care Holdings, Inc.
Blood Pump Rotor, Model Number: F40015481 Rev AAn increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Class II
Medical Device Recall · April 16, 2024
EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
Stryker Blueprint Software, Catalog #BPUE001.The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.
- Class II
Medical Device Recall · April 16, 2024
COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and aA potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
- Class II
Medical Device Recall · April 16, 2024
MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter DefibrillatorPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 16, 2024
Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1. c. CLARIA MRIPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Class II
Medical Device Recall · April 15, 2024
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity