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Direct Filing of Elmiron Retinal Injury Cases Permitted in Federal MDLApr, 13 2021
A federal judge has allowed direct filing of future Elmiron lawsuits over claims of vision loss.… The post Direct Filing of Elmiron Retinal Injury Cases Permitted in Federal MDL appeared first on AboutLawsuits.com.
New York Nursing Homes Must Spend 70% of Revenue On Direct Patient Care Under Proposed ReformsApr, 13 2021
New York is putting in place several measures to address nursing home problems which may have contributed to the high rate of COVID-19 infections and deaths seen in that state.… The post New York Nursing Homes Must Spend 70% of Revenue On Direct Patient Care Under Proposed Reforms appeared first on AboutLawsuits.com.
Pet Owner Files Class Action Lawsuit Over Seresto Flea Collars, After Dog DiedApr, 13 2021
A New York woman has filed a Seresto class action lawsuit on behalf of owners whose pets died after using the allegedly toxic collars.… The post Pet Owner Files Class Action Lawsuit Over Seresto Flea Collars, After Dog Died appeared first on AboutLawsuits.com.
FDA Investigates Reports of Johnson & Johnson COVID-19 Vaccine Blood Clot ProblemsApr, 13 2021
The FDA and CDC are calling for a pause in the use of the Johnson & Johnson COVID-19 vaccine until they can review incidents of rare and severe blood clots associated with the injections. … The post FDA Investigates Reports of Johnson & Johnson COVID-19 Vaccine Blood Clot Problems appeared first on AboutLawsuits.com.
ThermaCor Infusion Set Recall Due To High Levels of Aluminum ExposureApr, 13 2021
Nearly 40,000 ThermaCor 1200 disposable infusion sets are being recalled due to the risk of aluminum exposure.… The post ThermaCor Infusion Set Recall Due To High Levels of Aluminum Exposure appeared first on AboutLawsuits.com.
Lawsuit Filed Over Breast Cancer Diagnosed Following Use of Belviq Diet DrugApr, 12 2021
A belviq breast cancer lawsuit claims the recalled weight loss pill was not tested adequately before being sold to the public.… The post Lawsuit Filed Over Breast Cancer Diagnosed Following Use of Belviq Diet Drug appeared first on AboutLawsuits.com.
Gardasil Vaccine Lawsuit Filed Over Autoimmune Disease RisksApr, 12 2021
A Gardasil lawsuit claims the HPV vaccine caused a teen girl to develop a host of autoimmune disorders and may not be effective in actually preventing cervical cancer.… The post Gardasil Vaccine Lawsuit Filed Over Autoimmune Disease Risks appeared first on AboutLawsuits.com.
Women More Likely To Suffer Long-Term Harm From Concussions Than Men: StudyApr, 12 2021
A new study suggests women take longer to recover from traumatic brain injuries than men.… The post Women More Likely To Suffer Long-Term Harm From Concussions Than Men: Study appeared first on AboutLawsuits.com.
FDA Calls For Transition Away From Decontaminated Disposable Respirators As Supply ReboundsApr, 12 2021
The FDA is urging hospitals to transition away from reusing disposable respirators, as supplies rebound with the approval of new models of N95 and other face masks.… The post FDA Calls For Transition Away From Decontaminated Disposable Respirators As Supply Rebounds appeared first on AboutLawsuits.com.
Medtronic Valiant Navion Thoracic Stent Graft System Recall Issued Due To Endoleaks and FracturesApr, 12 2021
The FDA has announced a Medtronic stent graft system recall after reports of malfunctions, serious injuries, and at least one death.… The post Medtronic Valiant Navion Thoracic Stent Graft System Recall Issued Due To Endoleaks and Fractures appeared first on AboutLawsuits.com.

2021 Medical Device RecallsApr, 12 2021
List of Medical Device recalls in 2021.
Smisson-Cartledge Biomedical, LLC Recalls ThermaCor 1200 Disposable Sets for Risk of Patient Contact to AluminumApr, 12 2021
The ThermaCor 1200 Disposable Sets are part of a portable fluid delivery device system and are being recalled for patient aluminum contact risk.
Medtronic Recalls Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) Due to Risk of Shortened Battery LifeApr, 12 2021
Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia, and Visia ICDs and CRT-Ds correct heart arrhythmia. Some devices may have shortened battery life.
NS NY Distributor Inc Issues Voluntary Nationwide Recall of Premium OrgaZen 7000 and Ginseng Power 5000 Due to Presence of Undeclared Sildenafil and/or TadalafilApr, 09 2021
NS NY Distributor Inc is voluntarily recalling all lots within expiry of Premium Orgazen 7000 and Ginseng Power 5000 capsules to the consumer level. FDA analyses has found the products to contain undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil are known as phosphodiesterase (PDE-5)
Medtronic Recalls Valiant Navion Thoracic Stent Graft System Due to Risk of Stent Fractures and Type III EndoleaksApr, 09 2021
The Medtronic Stent Graft System is used to repair descending thoracic aortic aneurysm. Use of the device may lead to stent fractures and endoleaks.
FDA Recommends Transition from Use of Decontaminated Disposable Respirators - Letter to Health Care Personnel and FacilitiesApr, 09 2021
Read more on the domestic supply of new respirators, including N95s and other FFRs, elastomeric respirators, powered air-purifying respirators (PAPRs)
Yolo Studio Issues Voluntary Nationwide Recall of PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 Due to the Presence of Undeclared TadalafilApr, 06 2021
Cliffside Park, NJ, Yolo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil. Tadalafil is ingredient known as a phosphodiesterase (PDE-5) in
QMART Issues Voluntary Nationwide Recall of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 Due to Presence of Undeclared Sildenafil and/or TadalafilApr, 05 2021
Elmwood Park, NJ, QMART is voluntarily recalling all lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 to the consumer level. FDA analysis has found the products to be tainted with undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil a
A-S Medication Solutions Issues Voluntary Nationwide Recall of Acetaminophen Extra Strength Tablets Contained in Health Essentials Kits Due to MislabelingApr, 02 2021
Libertyville, IL, A-S Medication Solutions, LLM (ASM) is voluntarily recalling 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles (NDC# 50090-5350-0) contained in Health Essentials Kits distributed by Humana to its members. See the photo below. This recall is being con
Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care ProvidersApr, 01 2021
The FDA wants to raise awareness among health care providers about the risk of infections associated with reprocessed urological endoscopes.
Lamictal (lamotrigine): Drug Safety Communication - Studies Show Increased Risk of Heart Rhythm Problems in Patients with Heart DiseaseMar, 31 2021
FDA review of study findings showed a potential increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease who are taking the seizure and mental health medicine lamotrigine (Lamictal).
Ummzy LLC Issues Voluntary Nationwide Recall of Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night Due to the Presence of Undeclared Tadalafil Sildenafil & VardenafilMar, 31 2021
Palisades Park, NJ, Ummzy LLC is voluntarily recalling all lots of Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Nightcapsules to consumer level. FDA analysis has found the product to contain undeclared tadalafil sildenafil & Vardenafil. Tadalafil, Sildenafil & Vardenafil are ingredientsknown as
Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates: FDA Safety CommunicationMar, 31 2021
The FDA is informing patients, caregivers, and health care providers about reported differences in complication rates among Acellular Dermal Matrix (ADM) products in implant-based breast reconstruction.
2021 Safety CommunicationsMar, 31 2021
The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.
Nuri Trading LLC Issues Voluntary Nationwide Recall of Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, 69MODE Blue 69, Due to the Presence of Undeclared Tadalafil, Sildenafil, and/ or VardenafilMar, 31 2021
Nuri Trading is voluntarily recalling all lots within expiry of Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69 capsules to the consumer level.FDA analyses have found these products to contain undeclared tadalafil, sildenafil, and/orvardenafil.Sildenafil,tadalafil
Apotex Corp. Issues Voluntary Nationwide Recall of Guanfacine Extended-Release Tablets 2mg Due to Trace Amounts of Quetiapine FumarateMar, 31 2021
Weston, Florida, Apotex Corp is voluntarily recalling three (3) lots of Guanfacine Extended-Release Tablets 2mg to the consumer level due to trace amounts of Quetiapine Fumarate in one lot RX1663. Out of an abundance of caution, lots RX1662 and RX1664 are also included in the scope of this voluntary
Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care ProvidersMar, 30 2021
Laboratories should expect some false negative results because the SARS-CoV-2 virus can mutate over time and not be detected.
Bit & Bet LLC Issues Voluntary Nationwide Recall of Thumbs Up 7 Blue 69K Due to Presence of Undeclared Sildenafil and TadalafilMar, 30 2021
Bit & Bet LLC is voluntarily recalling all lots of Thumbs Up 7 Blue 69K capsules to consumer level. FDA analysis has found the product to contain undeclared sildenafil and tadalafil. Sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved produc
Mammography Problems at Tennessee Women’s Care P.C. in Nashville, TN: FDA Safety CommunicationMar, 30 2021
The FDA is alerting patients who had mammograms at Tennessee Women’s Care P.C., located in Nashville, Tennessee, on or after November 1, 2019, about possible problems with the quality of their mammograms.
Antoto-K Issues Voluntary Nationwide Recall of Thumbs Up 7 Red 70K Due to the Presence of Undeclared Sildenafil and TadalafilMar, 29 2021
Manassas, VA, Antoto-K is voluntarily recalling all lots of Thumbs Up 7 Red 70K, 10 capsules to consumer level. FDA analysis has found the product to contain undeclared Sildenafil and Tadalafil. Sildenafil and Tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA appro