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.
- 2021-07-21FDA-DeviceBaxter Healthcare CorporationClass IIEASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date
- 2021-07-21FDA-DeviceIMPLANTCAST GMBHClass IIEcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless 50mm dia incl. central hole cover; 02200052 /EcoFit cup cementless 52mm dia incl. central hole cover; 02200054 /EcoFit cup cementless 54mm dia incl. central hole cover; 02200056 /EcoFit cup cementless 56mm dia incl. central hole cover; 02200058 /EcoFit cup cementless
A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning note is being added to instructions for use and surgical technique alerting users that the quality of bone in the patient (such as osteosclerosis) is an attributable factor.
- 2021-07-21FDA-DeviceRanD S.r.l.Class IICh24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.
- 2021-07-21FDA-DeviceRanD S.r.l.Class IIHang&Go (kit for hyperthermic perfusion), Reference Code R9900120
The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.
- 2021-07-21FDA-DeviceCanon Medical System, USA, INC.Class IICanon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
- 2021-07-21FDA-DeviceCanon Medical System, USA, INC.Class IICanon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
- 2021-07-21FDA-DeviceCanon Medical System, USA, INC.Class IICanon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
- 2021-07-21FDA-DeviceCanon Medical System, USA, INC.Class IIToshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
- 2021-07-21FDA-DeviceTornier, IncClass IIAequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
- 2021-07-21FDA-DeviceBoston Scientific CorporationClass IINLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population
- 2021-07-21FDA-DeviceBoston Scientific CorporationClass IINTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population
- 2021-07-21FDA-DeviceBoston Scientific CorporationClass IINVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population
- 2021-07-21FDA-DeviceBoston Scientific CorporationClass IVITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population
- 2021-07-21FDA-DeviceBoston Scientific CorporationClass IINGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population
- 2021-07-21FDA-DeviceBoston Scientific CorporationClass IADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population
- 2021-07-21FDA-DevicePhilips Respironics, Inc.Class ISystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
- 2021-07-21FDA-DevicePhilips Respironics, Inc.Class IDreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
- 2021-07-21FDA-DevicePhilips Respironics, Inc.Class IPhilips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
- 2021-07-21FDA-DevicePhilips Respironics, Inc.Class IA-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
- 2021-07-21FDA-DevicePhilips Respironics, Inc.Class IA-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
- 2021-07-21FDA-DevicePhilips Respironics, Inc.Class ITrilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
- 2021-07-14FDA-DeviceMedtronic Heart Valves DivisionClass IICoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
- 2021-07-14FDA-DeviceMedtronic Heart Valves DivisionClass IICoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
- 2021-07-14FDA-DeviceMedtronic Heart Valves DivisionClass IICoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
- 2021-07-14FDA-DeviceBioFire Diagnostics, LLCClass IIFilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)
Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
- 2021-07-14FDA-DeviceBioFire Diagnostics, LLCClass IIFilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)
Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
- 2021-07-14FDA-DeviceCardinal Health 200, LLCClass IINonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
- 2021-07-14FDA-DeviceCardinal Health 200, LLCClass IISterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
- 2021-07-14FDA-DeviceCardinal Health 200, LLCClass IINonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
- 2021-07-14FDA-DeviceCardinal Health 200, LLCClass IISterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
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