06
February
0
Comments
Michigan Man Charged with Drug Distribution and Loan Fraud
in FDA News
FDA-OCI, Boston, Massachusetts, Michigan, Donald Nchamukong, Doyal Kalita Read More (external link)...
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FDA News
06
February
Hell’s Kitchen Aesthetician Arrested For Unlawfully Injecting Counterfeit Botox
in FDA News
FDA-OCI, JGL Aesthetics, Manhattan, New York, Hell's Kitchen, Joey Grant Luther Read More (external link)...
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06
February
Turkana Food Inc. Recalls Aleppo Tahini Sesame Paste 1lb (16oz) Because of Possible Health Risk
in FDA News
Turkana Food Inc. Kenilworth, NJ is recalling 858 cases OF Aleppo Tahini Sesame Paste because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune system Read More (external link)...
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06
February
Early Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular
in FDA News
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...
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06
February
Arterial Catheter Recall: Medline Industries, LP, Removes Integrated Arterial Catheters due to Excess Material at Catheter Hub that May Detach
in FDA News
Medline Integrated Arterial Catheters continuously monitor blood pressure. Excess material on the catheter hub that may detach and enter the patient. Read More (external link)...
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05
February
FDA Alerts Patients to Regularly Check Diabetes-Related Smartphone Device Alert Settings, Especially Following Phone Hardware or Software Changes
in FDA News
The FDA is alerting users of diabetes-related medical devices that smartphones connected to diabetes devices may fail to send critical safety alerts. Read More (external link)...
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05
February
Continuous Ventilator Correction: Baxter Healthcare Corporation Issues Correction for Life2000 Ventilator due to a nonconforming battery charger, which triggers a battery alarm and renders the ventilator inoperable
in FDA News
Baxter Healthcare is recalling the Life2000 Ventilator System by correction, due to a defective battery charger making the ventilator inoperable. Read More (external link)...
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05
February
Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due to the devices spontaneously catching fire
in FDA News
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD is recalling certain devices due to incidents of device melting and fire during the use of oxygen concentrators. Read More (external link)...
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03
February
Pressure Monitoring Device Recall: Medtronic Neurosurgery Issues Correction for Becker and Exacta External Drainage and Monitoring Systems Due to Cracks And/Or Leaks in Stopcocks
in FDA News
Becker and Exacta EDMS are used for draining and monitoring cerebrospinal fluid in the brain. Stopcocks may have cracks or leaks that pose a risk to patients. Read More (external link)...
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31
January
Gerber Products Company Announces Recall and Discontinuation of All Batches of Gerber® Soothe N Chew® Teething Sticks Due To Choking Hazard
in FDA News
January 31, 2025 — Gerber Products Company is initiating a recall and discontinuation of all batches of GERBER® SOOTHE N CHEW® TEETHING STICKS due to a potential choking hazard for babies and young children Read More (external link)...
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31
January
Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System
in FDA News
Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal s Read More (external link)...
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31
January
Blue Ridge Beef Issues a Recall of Blue Ridge Beef Natural Mix Due to Salmonella Contamination
in FDA News
January 31, 2025– Blue Ridge Beef is recalling 5,700 lbs. of their 2 lb log Natural Mix due to a contamination of Salmonella. Lot # N25/12/31 (Lot numbers are stamped in the clips on the end of the chubs/bags) UPC# 854298001054. Read More (external link)...
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31
January
Update on Alert: Extracorporeal Blood Circuit Issue from Nuwellis
in FDA News
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...
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31
January
Update on Alert: Fluid Delivery Set Issue from Medline
in FDA News
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...
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31
January
Update on Alert: Nephroscope Sheath Issue from Trokamed GmbH
in FDA News
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...
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31
January
Update on Alert: Infusion Pump Issue from Fresenius Kabi USA
in FDA News
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...
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31
January
Update on Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus
in FDA News
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...
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31
January
Gas Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitator Due to An Undersized Spring in The Controller That May Prevent the Device from Delivering the Required Pressure Levels Needed for Effective Ventilation
in FDA News
Mercury Medical recalls the Neo-Tee T-Piece Resuscitator due to the controller potentially not delivering the pressure levels needed for effective ventilation. Read More (external link)...
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30
January
United Natural Trading LLC Announces Allergy Alert for Undeclared Milk in Fresh Direct Dark Chocolate Covered Pretzels
in FDA News
January 29, 2025 – United Natural Trading LLC, Edison, NJ, is voluntarily recalling Fresh Direct Dark Chocolate Covered Pretzels due to the presence of an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction Read More (external link)...
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30
January
Glucose and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues Software Correction for StatStrip Glucose and Glucose/Ketone Hospital Meters Due to Risk for Transmission of Incorrect Patient Results
in FDA News
StatStrip Hospital Glucose and Ketone Meters provide blood glucose and ketone readings in health care settings. A software issue may transmit inaccurate results to patient records. Read More (external link)...
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