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FDA MedWatch

Clinically important safety information regarding human medical products
May 26, 2023 at 12:28 AM
FDA Updating Warnings to Improve Safe Use of Prescription Stimulants Used to Treat ADHD and Other Conditions.
The FDA is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class of these medicines to address continuing concerns of misuse, abuse, addiction, and overdose of prescription stimulants.
May 25, 2023 at 12:00 AM
2023 Medical Device Recalls
2023 Medical Device Recalls
May 25, 2023 at 12:00 AM
SD BioSensor, Inc. Recalls Certain Pilot COVID-19 At-Home Tests for Potential Bacteria Contamination
SD BioSensor is recalling some Pilot COVID-19 At-Home Tests for the risk that a bacteria contamination could harm users or cause false test results.
May 24, 2023 at 12:00 AM
Draeger Medical Recalls Seattle PAP Plus and Breathing Circuit/Anesthesia Kits for Risk of Loose or Detached Components That Can Restrict Breathing Support
Draeger Seattle PAP Plus and some breathing circuit or anesthesia kits may have parts that loosen or detach, preventing needed breathing support.
May 24, 2023 at 12:00 AM
2023 Medical Device Recalls
2023 Medical Device Recalls
May 22, 2023 at 12:00 AM
ICU Medical Recalls Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Due to Diminished Battery Life that May Impact Infusion Delivery
Replacement batteries for ICU Medical’s Plum 360, Plum A+ and Plum A+3 large volume infusion pumps may have shorter than expected battery life.
May 22, 2023 at 12:00 AM
2023 Medical Device Recalls
2023 Medical Device Recalls
May 19, 2023 at 12:00 AM
Novis PR LLC Issues Voluntary Recall of G-Supress DX Pediatric Drops Due to Incorrect Packaging
San Juan, PR, Novis PR LLC is voluntarily recalling Lot D20911 Exp 10/25 of G-Supress DX Pediatric Drops to the consumer level. Some cartons of the product have been found to contain incorrect product inside. Incorrect product inside is an anesthetic/analgesic and not a brand of Novis PR LLC.
May 19, 2023 at 12:00 AM
Novis PR LLC Emite Retiro Voluntario de Gotas Pediátricas G-Supress DX Debido a Empaque Incorrecto
San Juan, PR, Novis PR LLC está retirando voluntariamente el lote D20911 Exp 10/25 de gotas pediátricas G-Supress DX a nivel de consumidor. Se ha encontrado que algunas cajas del producto contienen un producto incorrecto en su interior. El producto incorrecto en el interior es un anestésico/analgési
May 17, 2023 at 12:00 AM
Update on Endologix AFX Endovascular AAA Graft Systems and Risk of Type III Endoleak: FDA Safety Communication
New labeling for AFX2 Endovascular AAA System (AFX2) includes information to better inform patients and health care providers of the risk of Type III endoleaks
May 17, 2023 at 12:00 AM
2023 Safety Communications
Listing of Medical Device 2023 Safety Communications
May 12, 2023 at 12:00 AM
BearCare Voluntarily Recalls Rechargeable Walnut Thermometer Due to the Potential for Skin Burns
BearCare, Inc. is initiating a voluntary recall of its rechargeable Walnut Wearable Smart Thermometer (Walnut Thermometer) due to reports of injuries, including skin burns, by users. The Walnut Thermometer is an over-the-counter rechargeable device intended for continuous chest temperature monitorin
May 10, 2023 at 12:00 AM
2023 Safety Communications
Listing of Medical Device 2023 Safety Communications
May 10, 2023 at 12:00 AM
UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication
Renuvion/J-Plasma device can be used for additional aesthetic skin procedures
May 10, 2023 at 12:00 AM
UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication
Renuvion/J-Plasma device can be used for additional aesthetic skin procedures
May 05, 2023 at 12:00 AM
Recall Notice - SD Biosensor, Inc. Requests Discontinuation of Use and Disposal of Specific Pilot™ COVID-19 At-Home Tests in the United States Due to Microbial Contamination in the Liquid Buffer Solution
SD Biosensor, Inc. today is requesting that consumers stop using and dispose of specific Pilot COVID-19 At-Home Tests in the United States because potentially harmful bacteria were found in the tube with liquid inside (pouch 2 of the kits). The affected tests can be identified by the lot number on
May 04, 2023 at 12:00 AM
2023 Safety Communications
Listing of Medical Device 2023 Safety Communications
May 04, 2023 at 12:00 AM
UPDATE - Akorn Issues Voluntary Nationwide Recall of Various Human and Animal Drug Products Within Expiry Due to Company Shutdown
Gurnee, IL, Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. The Akorn Trustee is initiating a voluntary recall of various w
May 04, 2023 at 12:00 AM
Do Not Use Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation: FDA Safety Communication
UV wands may cause injury to the skin, eyes, or both after a few seconds of use.
May 04, 2023 at 12:00 AM
Family Dollar is Initiating a Voluntary Recall of Certain Over-the-Counter Drug Products Because the Products Have Been Stored Outside of Labeled Temperature Requirements
Family Dollar is initiating a voluntary retail level product recall of certain over-the-counter drug products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to certain stores on or around June 1, 2022 through March 31, 2023 due to product being stored by Family
May 04, 2023 at 12:00 AM
Risk of Exposure to Unsafe Levels of Radiation with Safe-T-Lite UV WAND: FDA Safety Communication
Max-Lux Safe-T-Lite UV-C WAND may cause injury to the skin, eyes, or both after a few seconds of use.
May 04, 2023 at 12:00 AM
Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety Communication
Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test.
May 02, 2023 at 12:00 AM
Avanos Medical Inc Recalls Certain BALLARD ACCESS Closed Suction Systems for Neonates/Pediatrics for Risk of Inadequate Ventilation, Other Injuries from Cracked Manifolds
A cracked manifold on some BALLARD ACCESS Closed Suction Systems may cause inadequate ventilation or other injury to vulnerable patients.
April 28, 2023 at 12:00 AM
Teva Initiates Voluntary Nationwide Recall of Specific Lots of FENTANYL Buccal Tablets CII Due to a Labeling Error
Teva Pharmaceuticals USA, has initiated a voluntary nationwide recall of specific lots of various strengths of FENTANYL Buccal Tablets CII to the Consumer Level. Teva USA manufactured and labeled these product lots exclusively for Mayne Pharma Inc. under Mayne’s label. This recall has been initiated
April 27, 2023 at 12:00 AM
Illumina Cybersecurity Vulnerability Affecting the Universal Copy Service Software May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers
Illumina cybersecurity vulnerability affecting the Universal Copy Service software may impact patient health results.
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