Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2017-06-21FDA-DeviceArrow International IncClass II1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4) ARROWg+ard Blue PSI Kit The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- 2017-06-21FDA-DeviceArrow International IncClass IIMulti-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- 2017-06-21FDA-DeviceArrow International IncClass II1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- 2017-06-21FDA-DeviceArrow International IncClass II1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features 3)Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue Plus (R) Catheter and Sharps Safety Features 4) Multi-Lumen Pressure Injectable Central Venous Catheterization Kit with Blue Flex Tip(R)ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Featur
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- 2017-06-21FDA-DeviceArrow International IncClass II1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- 2017-06-21FDA-DeviceArrow International IncClass IISingle-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- 2017-06-21FDA-DeviceArrow International IncClass IIArterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- 2017-06-21FDA-DevicePentax of America IncClass IIVideo Naso pharyngo Laryngoscopes
This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.
- 2017-06-21FDA-DevicePentax of America IncClass IIVideo Cytoscopes
This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.
- 2017-06-21FDA-DevicePentax of America IncClass IIVideo Bronchoscope
This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.
- 2017-06-21FDA-DeviceGE Healthcare, LLCClass IIInfant Warmer System (IWS)
GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.
- 2017-06-21FDA-DevicePhilips Electronics North America CorporationClass IIPhilips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211)
Tube arm assembly could fall down due to cracked welding joints
- 2017-06-21FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare Discovery NM/CT 570c X-ray system
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- 2017-06-21FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare Discovery NM/CT 670 CZT X-ray system
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- 2017-06-21FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- 2017-06-21FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare Discovery Ml X-ray system
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- 2017-06-21FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare Discovery IQ X-ray system
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- 2017-06-21FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare Discovery Ml DR X-ray system
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- 2017-06-21FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX X-ray system
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- 2017-06-21FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare Lightspeed RT16 X-ray system
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- 2017-06-21FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare BrightSpeed X-ray system
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- 2017-06-21FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare lnnova IGS 540 ACT X-ray system
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- 2017-06-21FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare Optima CT540 X-ray system
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- 2017-06-21FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare Optima CT520 X-ray system
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- 2017-06-21FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- 2017-06-21FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare LightSpeed VCT X-ray system
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- 2017-06-21FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare Optima CT660, CT680 X-ray system
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- 2017-06-21FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare Revolution EVO X-ray system
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
- 2017-06-21FDA-DevicePhilips Electronics North America CorporationClass IIPhilips DigitalDiagnost 3.1.x X-Ray System
During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions.
- 2017-06-14FDA-DeviceOrthoPediatrics CorpClass IIResponse BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening.
Over-tensioning of the band resulting in damage to the band causing it to rupture
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief