Date Issued: August 29, 2022 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or …
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Intera 3000 Hepatic Artery Infusion Pump Models: See Recall Database entry Devices …
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Medtronic HVAD Batteries Model Numbers: 1650DE Devices Being Recalled: 23,372 Dates …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Device Use Medtronic Cobalt/Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac …
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The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Dewei Medical Equipment Co. DNA/RNA Preservation Kits Product Catalog Number: DW- …
Date Issued: August 11, 2022 Perform repeat, or serial testing following a negative result on any at-home COVID-19 test, whether or not you have symptoms. The U.S. Food and Drug Administration (FDA) is advising people to perform repeat, or serial, testing …
Date Issued: July 20, 2022 UV wands may introduce health risks to the user or a person nearby. The U.S. Food and Drug Administration (FDA) is warning consumers about the potential risk of injury associated with the use of certain brands of ultraviolet (UV …
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: BD Intraosseous Needle Set Kits, BD Intraosseous Manual Driver Kits, BD Intraosseous …
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Device Use Haimen Shengbang Laboratory Equipment Co. Ltd.’s Viral Transport Media Container is a …
September 8, 2022 The U.S. Food and Drug Administration (FDA) is alerting health care providers about potential clip lock malfunctions with MitraClip Clip Delivery Systems manufactured by Abbott. On September 8, 2022, Abbott issued an Urgent Medical Device …
Date Issued: September 8, 2022 The U.S. Food and Drug Administration (FDA) is informing the public about reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas, in the scar tissue (capsule) that forms around breast implants. The …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Palindrome and Mahurkar Hemodialysis Catheters Product Codes: MSD Model Numbers: …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Abacus Order Entry and Calculation Software Product Codes: See medical device …
Date Issued: July 21, 2022 The U.S. Food and Drug Administration (FDA) is providing another update on the Renuvion/J-Plasma device system by Apyx Medical about use of the device for certain aesthetic skin procedures. In March 2022, the FDA warned against …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …
