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Potential for Internal Pump Malfunction in the Medtronic HVAD System – Letter to Health Care Providers

The FDA is issuing this letter to ensure you are aware of this defect and the recommended actions to take to manage the care of patients currently implanted with a Medtronic HVAD system.

http://www.fda.gov/medical-devices/letters-health-care-providers/potential-internal-pump-malfunction-medtronic-hvad-system-letter-health-care-providers

 
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Woodside Acquisitions Inc. Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) That Are Not Authorized, Cleared, or Approved by the FDA

Woodside Acquisitions Inc. recalls COVID-19 Rapid Test Kits because they are not authorized, cleared, or approved by the FDA.

http://www.fda.gov/medical-devices/medical-device-recalls/woodside-acquisitions-inc-recalls-oral-rapid-sars-cov-2-antigen-rapid-test-kits-and-joysbio-sars-cov

 
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Green Pharmaceuticals Inc Issues Voluntary Nationwide Recall of SnoreStop NasoSpray Due to Microbial Contamination

Camarillo, California, Green Pharmaceuticals Inc is voluntarily recalling lot 2373/21222 of SnoreStop NasoSpray, packaged in 0.3 FL OZ (9ml) bottles to the consumer level. FDA testing found product to contain microbial contamination identified as Providencia rettgeri. This microorganism is rarely as

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/green-pharmaceuticals-inc-issues-voluntary-nationwide-recall-snorestop-nasospray-due-microbial

 
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Atrium Medical Corporation Recalls iCast Covered Stent for Potential Balloon or Catheter Hub Separation That May Cause Patient Harm

The iCast catheter-placed stent supports the walls of structure within the body. The balloon or catheter hub may separate during removal, causing harm to the patient.

http://www.fda.gov/medical-devices/medical-device-recalls/atrium-medical-corporation-recalls-icast-covered-stent-potential-balloon-or-catheter-hub-separation

 
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Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination

Lawrence, Kansas – Plastikon Healthcare, LLC is voluntarily recalling one (1) lot of Milk of Magnesia 2400 mg/10 mL Oral Suspension, one (1) lot of Milk of Magnesia 2400 mg/30 mL Oral Suspension, eleven (11) lots of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/plastikon-healthcare-issues-voluntary-nationwide-recall-milk-magnesia-oral-suspension-and-magnesium

 
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Buzzagogo, Inc. Issues Voluntary Nationwide Recall of Allergy Bee Gone for Kids Nasal Swab Remedy Due to Potential Microbial Contamination

Nottingham, NH, Buzzagogo Inc. is voluntarily recalling one lot of Allergy Bee Gone for Kids Nasal Swab Remedy to the consumer level due to potential microbial contamination. FDA testing found some product to contain elevated levels of yeast & mold and may contain the bacteria Bacillus cereus.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/buzzagogo-inc-issues-voluntary-nationwide-recall-allergy-bee-gone-kids-nasal-swab-remedy-due