MedWatch Safety Alerts

2021 Medical Device Recalls

List of Medical Device recalls in 2021

NS NY Distributor Inc Issues Voluntary Nationwide Recall of Premium OrgaZen 7000 and Ginseng Power 5000 Due to Presence of Undeclared Sildenafil and/or Tadalafil

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

FDA Recommends Transition from Use of Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities

Read more on the domestic supply of new respirators, including N95s and other FFRs, elastomeric respirators, powered air-purifying respirators (PAPRs

Medtronic Recalls Valiant Navion Thoracic Stent Graft System Due to Risk of Stent Fractures and Type III Endoleaks

The Medtronic Stent Graft System is used to repair descending thoracic aortic aneurysm. Use of the device may lead to stent fractures and endoleaks

Yolo Studio Issues Voluntary Nationwide Recall of PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 Due to the Presence of Undeclared Tadalafil

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

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 Tadalafil

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

A-S Medication Solutions Issues Voluntary Nationwide Recall of Acetaminophen Extra Strength Tablets Contained in Health Essentials Kits Due to Mislabeling

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

Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers

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 Disease

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

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 Vardenafil

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.

Apotex Corp. Issues Voluntary Nationwide Recall of Guanfacine Extended-Release Tablets 2mg Due to Trace Amounts of Quetiapine Fumarate

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

2021 Safety Communications

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

Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates: FDA Safety Communication

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

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 & Vardenafil

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

Bit & Bet LLC Issues Voluntary Nationwide Recall of Thumbs Up 7 Blue 69K Due to Presence of Undeclared Sildenafil and Tadalafil

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

Mammography Problems at Tennessee Women’s Care P.C. in Nashville, TN: FDA Safety Communication

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

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 Providers

Laboratories should expect some false negative results because the SARS-CoV-2 virus can mutate over time and not be detected

Antoto-K Issues Voluntary Nationwide Recall of Thumbs Up 7 Red 70K Due to the Presence of Undeclared Sildenafil and Tadalafil

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

UPDATE: The FDA Reminds Patients and Health Care Providers of the Importance of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication

The FDA is updating our October 28, 2019 safety communication on the use of AFX endovascular grafts with Duraply material (AFX with Duraply or AFX2

Namoo Enterprise LLC Issues Voluntary Nationwide Recall of PremierZen Black 5000 Due to the Presence of Undeclared Sildenafil and Tadalafil

Little Ferry, NJ, Namoo Enterprise LLC is voluntarily recalling all lots within expiry of PremierZen Black 5000 capsules to the consumer level. FDA analysis has found the product

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