Skip to Main Content
June 05, 2023 at 12:00 AM
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
The FDA posts letters to health care providers about the safe use of medical devices.
June 05, 2023 at 12:00 AM
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
June 02, 2023 at 12:00 AM
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
Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall
May 30, 2023 at 12:00 AM
Listing of Medical Device 2023 Safety Communications
May 26, 2023 at 12:28 AM
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
May 25, 2023 at 12:00 AM
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 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
May 22, 2023 at 12:00 AM
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
May 19, 2023 at 12:00 AM
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
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
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
Listing of Medical Device 2023 Safety Communications
May 12, 2023 at 12:00 AM
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
Listing of Medical Device 2023 Safety Communications
May 10, 2023 at 12:00 AM
Renuvion/J-Plasma device can be used for additional aesthetic skin procedures
May 10, 2023 at 12:00 AM
Renuvion/J-Plasma device can be used for additional aesthetic skin procedures
May 10, 2023 at 12:00 AM
El dispositivo Renuvion/J-Plasma puede utilizarse para otros procedimientos cutáneos estéticos.
May 05, 2023 at 12:00 AM
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
Listing of Medical Device 2023 Safety Communications