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Safety Reports: Medical Devices

Updated: September 6, 2022 7:00 PM

Real Time Reports

Recall notice

Philips Respironics CPAP or Bi-Level PAP therapy masks - recalled due to potential risk of serious injury, USA

3 years ago •source fda.gov • details

These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

Royal Philips’ (NYSE: PHG; AEX: PHIA) subsidiary Philips Respironics is alerting… See more

#blood #recall #medicaldevices #unitedstates #sub #hunts

Recalls Philips Respironics CPAP or Bi-Level PAP therapy masks - recalled due to potential risk of serious i... photo #1

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Recall notice

Intraosseous Products - recalled due to limited or non-functioning intraosseous access, USA

3 years ago •source fda.gov • details

BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on the BDTM Intraosseous Needle Set Kits, BDTM Intraosseous Manual Driver Kits and BDTM Intraosseous Powered Drivers. Certain lots within the expiration date of these intraosseous products may result in the following:… See more

#medicaldevices #unitedstates

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Recall notice

Volara System (home care) - recalled due to possible risk of oxygen desaturation, USA

3 years ago •source fda.gov • details

Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Volara System (home care) to reinforce important safety information regarding a possible risk of decrease in oxygen levels (oxygen desaturation) or injury that may result in lung tissue damage due to over-expansion… See more

#medicaldevices #unitedstates

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Recall notice

Philips Respironics V60/V60 Plus, and V680 - recalled due to potential power supply issue, USA

3 years ago •source fda.gov • details

Royal Philips (NYSE: PHG, AEX: PHIA), today announced that its subsidiary Philips Respironics is notifying customers of its V60/V60 Plus and V680 ventilators about a potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm. Philips Respironics… See more

#recall #medicaldevices #unitedstates #sub #ro-tel

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Recall notice

Family Dollar Drugs, Medical Devices, Cosmetics, & Food products - recalled due to Salmonella and rodent contamination, USA

3 years ago •source fda.gov • details

Family Dollar, Inc. is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to 404 stores from Family Dollar Distribution Center 202 in West Memphis, Arkansas from January 1, 2021 through the… See more

#petfood #mice #rats #rodents #medicaldevices #drugs #recall #dogfood #catfood #familydollar #unitedstates #applegate #arnold

Recalls Family Dollar Drugs, Medical Devices, Cosmetics, & Food products - recalled due to Salmonella and ro... photo #1

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Recall notice

Spectrum V8 and Spectrum IQ infusion pumps - recalled due to alarm malfunction, USA

3 years ago •source fda.gov • details

Baxter International Inc. announced today it has issued an Urgent Safety Communication to reinforce important safety information regarding upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusion pumps. Incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms may result in reduced delivery or… See more

#recall #medicaldevices #unitedstates #ham #bean #roll #ro-tel

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Recall notice

STANDARD Q COVID-19 Ag Home Test - recalled due to illegally imported into the US, USA

3 years ago •source fda.gov • details

SD Biosensor, Inc., a global in-vitro diagnostics company, is voluntarily recalling its STANDARD Q COVID-19 Ag Home Test in the United States, due to confirmed reports that the test kits were illegally imported into the United States. The STANDARD Q COVID-19 Ag Home Test is not authorized,… See more

#recall #medicaldevices #unitedstates

Recalls STANDARD Q COVID-19 Ag Home Test - recalled due to illegally imported into the US SD Biosensor, Inc.... photo #1

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Recall notice

Vyaire Medical ventilators - recalled due technical failure alarm, USA

3 years ago •source fda.gov • details

Imtmedical ag, a subsidiary of Vyaire Medical, initiated a voluntary field correction for certain bellavista™ ventilators. With specific software version and configuration combinations, the ventilators can cease ventilation and generate a technical failure alarm 305. There is a potential issue with bellavista™ 1000 and 1000e ventilators that… See more

#recall #medicaldevices #unitedstates

Recalls Vyaire Medical ventilators - recalled due technical failure alarm Imtmedical ag, a subsidiary of Vya... photo #1

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Recall notice

Oscor Destino Twist & Guidestar - recalled due to potential detachment, USA

4 years ago •source fda.gov • details

Oscor Inc. is voluntarily recalling 14 lots of Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 down to the user level. The Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 have been found to have increased risk of the hub cap and seal… See more

#recall #medicaldevices #unitedstates

Recalls Oscor Destino Twist & Guidestar - recalled due to potential detachment Oscor Inc. is voluntarily rec... photo #1

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Recall notice

Cardinal Health’s Monoject™ Prefilled Syringes - recalled due to potential air draw back, USA

4 years ago •source fda.gov • details

On August 19, 2021, Aligned Medical Solutions initiated a nationwide recall of Cardinal Health’s Monoject™ Flush Prefilled Saline Syringes placed into 9,378 kits. Including:
- 1 lot of AMS-9041CP Leaderflex Insertion Kit with Ultrasound
- 1 lot of AMS-9046CP-1 Insertion Tray-RX
- 45 lots of AMS8939A Universal… See more

#recall #medicaldevices #unitedstates

Recalls Cardinal Health’s Monoject™ Prefilled Syringes - recalled due to potential air draw back On August 1... photo #1

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Safety Reports: Medical Devices

Real Time Reports

Philips Respironics CPAP or Bi-Level PAP therapy masks - recalled due to potential risk of serious injury, USA

Intraosseous Products - recalled due to limited or non-functioning intraosseous access, USA

Volara System (home care) - recalled due to possible risk of oxygen desaturation, USA

Philips Respironics V60/V60 Plus, and V680 - recalled due to potential power supply issue, USA

Family Dollar Drugs, Medical Devices, Cosmetics, & Food products - recalled due to Salmonella and rodent contamination, USA

Spectrum V8 and Spectrum IQ infusion pumps - recalled due to alarm malfunction, USA

STANDARD Q COVID-19 Ag Home Test - recalled due to illegally imported into the US, USA

Vyaire Medical ventilators - recalled due technical failure alarm, USA

Oscor Destino Twist & Guidestar - recalled due to potential detachment, USA

Cardinal Health’s Monoject™ Prefilled Syringes - recalled due to potential air draw back, USA

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