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FDA MedWatch

Clinically important safety information regarding human medical products
June 05, 2023 at 12:00 AM
Non-sterile, Single-use Pneumatic Tourniquet Cuffs Conservation Strategies - Letter to Health Care Providers
Read the recommendations for health care facilities and providers due to localized supply constraints of non-sterile, single-use pneumatic tourniquet cuffs.
June 05, 2023 at 12:00 AM
2023 Letters to Health Care Providers
The FDA posts letters to health care providers about the safe use of medical devices.
June 05, 2023 at 12:00 AM
Abiomed Recalls Specific Impella 5.5 with SmartAssist for Purge Fluid Leaks that Can Cause Pump Stop and Loss of Support
Impella provides short-term pumping support to the heart. Purge fluid leaks may cause the pump to stop providing necessary therapy for critical patients.
June 02, 2023 at 12:00 AM
2023 Medical Device Recalls
2023 Medical Device Recalls
June 02, 2023 at 12:00 AM
UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
This update provides additional information on the recall and recommendations for people who use repaired and replaced devices.
June 02, 2023 at 12:00 AM
FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls
Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall
May 30, 2023 at 12:00 AM
2023 Safety Communications
Listing of Medical Device 2023 Safety Communications
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 10, 2023 at 12:00 AM
ACTUALIZACIÓN: Uso del dispositivo Renuvion/J-Plasma para determinados procedimientos estéticos: Comunicación de seguridad de la FDA
El dispositivo Renuvion/J-Plasma puede utilizarse para otros procedimientos cutáneos estéticos.
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
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