MedWatch Safety Alerts

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

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

2022 Safety Communications

Listing of Medical Device 2022 Safety Communications

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

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

Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended- Release Tablets, USP 750 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Cranford, New Jersey, Viona Pharmaceuticals Inc., is voluntarily recalling thirty three (33) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail

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

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

2022 Medical Device Recalls

List of Medical Device recalls in 2022

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

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

Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Due to Reports of Fluid Leaks

Getinge/Datascope/Maquet recalls the Cardiosave IABP after complaints of fluid leaks causing the system to shut down

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

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Clobetasol Propionate Ointment USP, 0.05%, 60 g Tubes, Lot AC13786 Due to Microbial Contamination

Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes, to the

Padagis Issues Voluntary Nationwide Recall for Nitroglycerin Lingual Spray Due to a Possible Defective Delivery System

December 27, 2021 – Padagis US LLC announced today it has issued a voluntary nationwide recall to the consumer/user level of the lots of Nitroglycerin Lingual Spray listed in the

Getinge’s Maquet/Datascope IABP Devices: Update on Device Failure – Letter to Health Care Providers

The FDA is updating information about Getinge’s Maquet/Datascope IABP devices including information about three voluntary recalls

Update On Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) is providing an update on our evaluation of device failures associated with Getinge's Maquet/Datascope intra-aortic balloon pump (IABP

Possible False RPR Reactivity with BioPlex 2200 Syphilis Total & RPR Test Kit Following a COVID-19 Vaccine - Letter to Clinical Laboratory Staff and Health Care Providers

False RPR Reactivity with BioPlex 2200 Syphilis Total & RPR following a COVID-19 Vaccine - Letter to Clinical Laboratory Staff and Health Care Providers

2021 Medical Device Recalls

List of Medical Device recalls in 2021

Potential Concerns with NuVasive MAGEC System Implants - FDA Safety Communication

Potential concerns in MAGEC system implants may include endcap separation and need for additional biocompatibility testing

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