US FDA News: Esupplementsales, LLC Issues a Nationwide Recall All Lots of Hard Dawn Due to the Presence of Undeclared Tadalafil

Orangevale, CA, Esupplementsales, LLC is voluntarily recalling lot number 2107 of Hard Dawn Rise and Shine capsules to the consumer level. Esupplementsales, LLC was informed by Amazon that laboratory analysis has found the product to be tainted with tadalafil, an ingredient known as a phosphodieste
Read more: Esupplementsales, LLC Issues a Nationwide Recall All Lots of Hard Dawn Due to the Presence of Undeclared Tadalafil

US FDA News: Coronavirus (COVID-19) Update: FDA Takes Key Action by Approving Second COVID-19 Vaccine

The FDA approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older.
Read more: Coronavirus (COVID-19) Update: FDA Takes Key Action by Approving Second COVID-19 Vaccine

US FDA News: FDA Roundup: January 28, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: January 28, 2022

US FDA News: Empowered Diagnostics Recalls COVID-19 Tests due to Risk of False Results

CovClear COVID-19 Rapid Antigen and ImmunoPass COVID-19 Neutralizing Antibody Rapid Tests recalled due to a risk of false results
Read more: Empowered Diagnostics Recalls COVID-19 Tests due to Risk of False Results

US FDA News: Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication

These tests have not been authorized, cleared, or approved. The FDA is concerned about the higher risk of false results when using these tests.
Read more: Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication

US FDA News: AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Polymyxin B for Injection USP, 500,000 Unit per Vial, Due to the Presence of Particulate Matter

East Windsor, New Jersey, AuroMedics Pharma LLC has initiated a voluntary recall of lot number CPB200013 of Polymyxin B for Injection USP, 500,000 Units/Vial, to the consumer level from the USA market due to a product complaint for the presence of particulate matter, identified as hair being discove
Read more: AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Polymyxin B for Injection USP, 500,000 Unit per Vial, Due to the Presence of Particulate Matter

US FDA News: Blaine Labs Issues Voluntary Nationwide Recall of RevitaDerm Wound Care Gel Due to Bacterial Contamination

Blaine Labs Company is voluntarily recalling one lot of RevitaDerm Wound Care to the consumer level because a bottle of the 1.0 ounce RevitaDerm Wound Care Gel has been found to be contaminated with Bacillus cereus. Patients who apply the contaminated product to a wound could develop a skin and soft
Read more: Blaine Labs Issues Voluntary Nationwide Recall of RevitaDerm Wound Care Gel Due to Bacterial Contamination

US FDA News: Philips Respironics Recalls Certain Trilogy EVO Ventilators for Potential Health Risks from PE-PUR Foam

Philips Respironics Recalls Certain Trilogy EVO Ventilators for Potential Health Risks from PE-PUR Foam
Read more: Philips Respironics Recalls Certain Trilogy EVO Ventilators for Potential Health Risks from PE-PUR Foam

US FDA News: Philips Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked Questions

Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall
Read more: Philips Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked Questions

US FDA News: FDA Roundup: January 25, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: January 25, 2022

US FDA News: Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant

The FDA revised the authorizations for two monoclonal antibody treatments to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible of these treatments.
Read more: Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant

US FDA News: FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19

The FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease in places such as skilled nursing facilities, home healthcare settings and outpatient facilities.
Read more: FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19

US FDA News: FDA Roundup: January 21, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: January 21, 2022

US FDA News: Medtronic Inc. Recalls HawkOne Directional Atherectomy System Due to Risk of Tip Damage During Use

This device is used during an atherectomy to treat patients who have calcified narrowings and blockages in the peripheral arteries.
Read more: Medtronic Inc. Recalls HawkOne Directional Atherectomy System Due to Risk of Tip Damage During Use

US FDA News: UPDATE: Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel

The FDA recommends conservation strategies to minimize the use of these tubes and maintain the quality and safety of care for patients.
Read more: UPDATE: Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel

US FDA News: Sodium Citrate Blood Specimen Collection Tube Conservation Strategies – Letter to Health Care and Laboratory Personnel

Sodium Citrate Blood Specimen Collection Tube Conservation Strategies
Read more: Sodium Citrate Blood Specimen Collection Tube Conservation Strategies – Letter to Health Care and Laboratory Personnel

US FDA News: Getinge USA Sales, LLC Recalls the Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems Due to a Risk of Harmful Chemical Exposure

Getinge USA Sales, LLC recalls its Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems due to a risk of harmful chemical exposure.
Read more: Getinge USA Sales, LLC Recalls the Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems Due to a Risk of Harmful Chemical Exposure

US FDA News: Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Recall of One Batch of Semglee® (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens, Due to the Potential for a Missing Label in the Batch

Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens, which are packaged in a labelled carton of five (5) pens. The product is being recalled due to the potential f
Read more: Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Recall of One Batch of Semglee® (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens, Due to the Potential for a Missing Label in the Batch

US FDA News: FDA Roundup: January 18, 2022

he U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: January 18, 2022

US FDA News: FDA Releases CDRH Health of Women Strategic Plan to Better Inform Medical Device Research and Regulation for All Women

The FDA’s Center for Devices and Radiological Health (CDRH) is sharing its Health of Women Program Strategic Plan to further the FDA’s mission by protecting and promoting the health of all women.
Read more: FDA Releases CDRH Health of Women Strategic Plan to Better Inform Medical Device Research and Regulation for All Women

US FDA News: FDA Roundup: January 14, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: January 14, 2022

US FDA News: FDA Releases Federal Interagency Working Group Scientific Opinions on Testing Methods for Asbestos in Talc-Containing Cosmetic Products

Interagency Working Group on Asbestos in Consumer Products (IWGACP) White Paper offers opinions on testing methods of talc-containing cosmetics products to assess the presence of asbestos
Read more: FDA Releases Federal Interagency Working Group Scientific Opinions on Testing Methods for Asbestos in Talc-Containing Cosmetic Products

US FDA News: Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems – FDA Safety Communication

Do not routinely use AFX2 endovascular grafts for patients with abdominal aortic aneurysms.
Read more: Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems – FDA Safety Communication

US FDA News: FDA Approves Novel Treatment to Control Pain in Cats with Osteoarthritis, First Monoclonal Antibody Drug for Use in Any Animal Species

FDA Approves Novel Treatment to Control Pain in Cats with Osteoarthritis, First Monoclonal Antibody Drug for Use in Any Animal Species
Read more: FDA Approves Novel Treatment to Control Pain in Cats with Osteoarthritis, First Monoclonal Antibody Drug for Use in Any Animal Species

US FDA News: Lohxa LLC Issues Voluntary Nationwide Recall of Senna Syrup 8.8mg/5mL Due to Microbial Contamination

Lohxa LLC is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups to the consumer level. The product is being recalled due to microbial contamination. Use of contaminated product by the elderly, patients with a weakened immune system, or patients at a higher risk of developing li
Read more: Lohxa LLC Issues Voluntary Nationwide Recall of Senna Syrup 8.8mg/5mL Due to Microbial Contamination

US FDA News: Buprenorphine: Drug Safety Communication - FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain

FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth.
Read more: Buprenorphine: Drug Safety Communication - FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain

US FDA News: Oscor Inc. Issues Voluntary Worldwide Recall of Destino Twist Steerable Guiding Sheath Due to the Risk of the Device Hub Cap and Seal on the Proximal End of the Device Handle Detachment During Use.

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 on the proximal end of the devic
Read more: Oscor Inc. Issues Voluntary Worldwide Recall of Destino Twist Steerable Guiding Sheath Due to the Risk of the Device Hub Cap and Seal on the Proximal End of the Device Handle Detachment During Use.

US FDA News: FDA Roundup: January 11, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: January 11, 2022

US FDA News: Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication

The tests are likely to have a high risk of false results and are not FDA authorized, cleared, or approved.
Read more: Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication

US FDA News: 2022 Safety Communications

Listing of Medical Device 2022 Safety Communications
Read more: 2022 Safety Communications

US FDA News: Cardiovascular Systems, Inc Recalls WIRION Embolic Protection Device Due to Complaints of Filter Breakage During Retrieval

Cardiovascular Systems, Inc Recalls WIRION Embolic Protection Device Due to Complaints of Filter Breakage During Retrieval
Read more: Cardiovascular Systems, Inc Recalls WIRION Embolic Protection Device Due to Complaints of Filter Breakage During Retrieval

US FDA News: FDA Roundup: January 7, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: January 7, 2022

US FDA News: Coronavirus (COVID-19) Update: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months

The FDA amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.
Read more: Coronavirus (COVID-19) Update: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months

US FDA News: Medtronic Recalls Synergy Cranial and StealthStation S7 Cranial Software Due to Potential Risk of Inaccurate Biopsy Depth Gauge Cycle View

Medtronic is recalling its Synergy Cranial and StealthStation S7 Cranial software due to the potential inaccuracy of the Biopsy Depth Gauge Cycle View.
Read more: Medtronic Recalls Synergy Cranial and StealthStation S7 Cranial Software Due to Potential Risk of Inaccurate Biopsy Depth Gauge Cycle View

US FDA News: FDA Roundup: January 4, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: January 4, 2022

US FDA News: Covidien, LP Recalls Puritan Bennett 980 Series Ventilator Due to Manufacturing Assembly Error

Covidien, LP (part of Medtronic) is recalling its Puritan Bennett 980 Series Ventilator due to a capacitor manufacturing assembly error.
Read more: Covidien, LP Recalls Puritan Bennett 980 Series Ventilator Due to Manufacturing Assembly Error

US FDA News: 2022 Medical Device Recalls

List of Medical Device recalls in 2022.
Read more: 2022 Medical Device Recalls

US FDA News: Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine

The FDA amended the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to take several actions that will expand the use of the vaccine in certain populations.
Read more: Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine