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Safety Reports: Medical Devices

Updated: June 2, 2022 5:00 PM

Real Time Reports

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

3 years ago •source fda.gov • details

Recall notice

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

3 years ago •source fda.gov • details

Recall notice

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

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

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

3 years ago •source fda.gov • details

Recall notice

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

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

Family Dollar Drugs, Medical Devices, Cosmetics, & Food products - recalled due to Salmonella and rodent contamination photo #1

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

3 years ago •source fda.gov • details

Recall notice

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

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

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

3 years ago •source fda.gov • details

Recall notice

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

#medicaldevices #recall #unitedstates

STANDARD Q COVID-19 Ag Home Test - recalled due to illegally imported into the US photo #1

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Vyaire Medical ventilators - recalled due technical failure alarm, USA

3 years ago •source fda.gov • details

Recall notice

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

#medicaldevices #recall #unitedstates

Vyaire Medical ventilators - recalled due technical failure alarm photo #1

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

3 years ago •source fda.gov • details

Recall notice

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

#medicaldevices #recall #unitedstates

Oscor Destino Twist & Guidestar - recalled due to potential detachment photo #1

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

3 years ago •source fda.gov • details

Recall notice

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

#medicaldevices #recall #unitedstates

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

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Cook Medical Transseptal Needle and Transseptal Needle Catheter - recalled due to Complaints of rust on the products, USA

3 years ago •source fda.gov • details

Recall notice

Company name: Cook Medical
Brand name: Cook Medical
Product recalled: Transseptal Needle and Transseptal Needle Catheter
Reason of the recall: Complaints of rust on the products
FDA Recall date: October 19, 2021
Recall details: Bloomington, Ind. — On October 8, 2021, Cook Medical issued a global, voluntary… See more

#medicaldevices #recall #unitedstates

Cook Medical Transseptal Needle and Transseptal Needle Catheter - recalled due to Complaints of rust on the products photo #1

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LeadCare® Test Kits - recalled due to underestimated blood lead levels, USA

3 years ago •source fda.gov • details

Recall notice

Company name: Meridian Bioscience, Inc.
Brand name: Meridian Bioscience, Inc.
Product recalled: LeadCare® Test Kits
Reason of the recall: LeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samples
FDA Recall date: September 02, 2021
Recall details: Meridian Bioscience, Inc. (NASDAQ: VIVO),… See more

#medicaldevices #recall #blood #unitedstates

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Safety Reports: Medical Devices

Real Time Reports

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

Cook Medical Transseptal Needle and Transseptal Needle Catheter - recalled due to Complaints of rust on the products, USA

LeadCare® Test Kits - recalled due to underestimated blood lead levels, USA

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