Medical device recalls
38751 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-02-09FDA-DeviceSmith & Nephew, Inc.Class IIINTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
- 2022-02-09FDA-DeviceSiemens Medical Solutions USA, Inc.Class IIACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's condition.
- 2022-02-09FDA-DeviceMicrobiologics IncClass IIIKWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of 7/31/2020 when it should have been 7/31/2022.
- 2022-02-09FDA-DeviceImmuno-Mycologics, IncClass IICRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919
The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before). As a result, a small number of samples with positive test results may be false positives, which may cause some patients to initiate unnecessary anti-fungal therapy. Samples with negative test results are NOT affected.
- 2022-02-09FDA-DeviceMicrobiologics IncClass IIIKWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
- 2022-02-09FDA-DeviceMicrobiologics IncClass IIIKWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
- 2022-02-09FDA-DeviceDIXI MEDICAL USAClass IIThe DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulati
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
- 2022-02-09FDA-DeviceDIXI MEDICAL USAClass IIThe DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulati
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
- 2022-02-09FDA-DeviceDIXI MEDICAL USAClass IIThe DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulati
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
- 2022-02-09FDA-DeviceDIXI MEDICAL USAClass IIThe DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulati
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
- 2022-02-09FDA-DeviceDIXI MEDICAL USAClass IIThe DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulati
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
- 2022-02-09FDA-DeviceDIXI MEDICAL USAClass IIThe DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulati
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
- 2022-02-09FDA-DeviceDIXI MEDICAL USAClass IIThe DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulati
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
- 2022-02-09FDA-DeviceDIXI MEDICAL USAClass IIThe DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulati
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
- 2022-02-09FDA-DeviceDIXI MEDICAL USAClass IIThe DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulati
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
- 2022-02-09FDA-DeviceXTANT MedicalClass IIX060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
- 2022-02-09FDA-DeviceLivaNova USA, Inc.Class IIVagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter)
A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing becomes completely breached, the patient may experience discomfort or pain due to delivery of stimulation to an unintended location. If the inner lead conductor is exposed to body fluids the lead may break causing loss of therapy.
- 2022-02-09FDA-DeviceBaxter Healthcare CorporationClass IBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.
- 2022-02-09FDA-DeviceBaxter Healthcare CorporationClass IBaxter Spectrum IQ Infusion Pumps, Product code 3570009.
There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.
- 2022-02-09FDA-DeviceEmpowered Diagnostics LLCClass IImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
- 2022-02-09FDA-DeviceEmpowered Diagnostics LLCClass ICovClear COVID-19 Rapid Antigen Test, ATG 900-031
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
- 2022-02-02FDA-DeviceFlexDex Inc.Class II8mm FlexDex Needle Driver, Product Code FD-335 ND
The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used.
- 2022-02-02FDA-DeviceNuVasive Specialized Orthopedics, Inc.Class IIMAGEC 1 System
Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.
- 2022-02-02FDA-DeviceVelano VascularClass IIPIVO Blood Collection Device 20G, REF: 202-0005
Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial contamination of the device prior to use. The health effects range from no clinical effect up to bloodstream infection.
- 2022-02-02FDA-DeviceNRT X-RAY A/SClass II1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table while in use with a patient. This accessory is designed to use with Intelli-C, Right and Intelli-C, Left.
- 2022-02-02FDA-DeviceBiomerieux IncClass IIAPI ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either automatically or manually and the identification is obtained using an identification software.
Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
- 2022-02-02FDA-DeviceGE Healthcare, LLCClass IIGE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
- 2022-02-02FDA-DeviceGE Healthcare, LLCClass IIGE Vscan Extend, being sold as "Vscan Extend Sector USB"
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
- 2022-02-02FDA-DeviceGE Healthcare, LLCClass IIGE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
- 2022-02-02FDA-DeviceGE Healthcare, LLCClass IIGE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
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