Coronary dilation catheters are used to open clogged blood vessels to improve blood flow to the heart, Abbot is recalling these devices due to failure of balloon to deflate in certain models, use may cause serious adverse health consequences, such as reduced blow flow to the heart and air embolism.
The ventilators are used on patients that need breathing support. The sound alarm on the ventilator may fail to alert, presenting a risk of injury or death.
The system provides heated and humidified breathing gases to patients. The system may malfunction causing water to enter the airway causing serious injury.
FDA has requested that the manufacturer voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer, Eisai Inc,. has submitted a request to voluntarily withdraw the drug.
2/13/2020 3:00:00 PM
Missing or broken retainer ring could cause under or over delivery of insulin. This may cause patient injury or death.
A loose cable connection could cause the loss of mechanical ventilation which could lead to serious injury or death.
A manufacturing problem could cause the displayed oxygen values to be incorrect which could lead to serious injury or death.
Efficient Laboratories, Inc. is voluntarily recalling one lot each of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAXliquid. Specifically, we are recalling the following lots: Rompe Pecho EX lot 19F332, exp June 2022, Rompe Pecho CF lot 19H359, exp August 2022 and Rompe Pecho MAX lot 19B42, ex
Regarding cybersecurity vulnerabilities identified in a wireless telemetry technology used for communication between Medtronic?s implantable cardiac devices, clinic programmers, and home monitors.
List of Medical Device recalls in 2020.
FDA is strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, uncommonly, progress to serious bowel complications. This can lead to hospitalization or even death if constipation is not diagnosed/treated.
1/28/2020 1:00:00 PM
The Babi.Plus Pressure Relief Manifold is used as part of a breathing circuit to assist infant patients to breathe. This device is being recalled due to a dislodged valve resulting in loss of pressure in the system. Teleflex issued a Medical Device Recall Notice to affected customers.
King Systems initiated a voluntary recall of One-Hundred Seventy-One (171) units of its King Vision Video Laryngoscope Adapter Size 1/2. The affected products have been found to exhibit a reversed image, which could potentially result in difficulty navigating during intubation and/or delay in intub
The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.
1/23/2020 7:00:00 AM
FDA is informing health care providers and facility staff about cybersecurity vulnerabilities that may introduce risks to patients while being monitored using certain GE Healthcare Clinical Information Central Stations and Telemetry Servers.
1/23/2020 7:00:00 AM
FDA is sharing recommendations and updates to help improve duodenoscope reprocessing.
1/17/2020 8:00:00 AM
The medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and accompanying PreSource procedural packs.
1/16/2020 2:00:00 PM
FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry, to the user level, due to a lack of assurance of sterility. The recalled sterile products have been found to be inconsistent with federal guidelines.
FDA is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin).
1/14/2020 10:00:00 AM
Taro Pharmaceuticals U.S.A., Inc. (?Taro? or the ?Company?) is voluntarily recalling one (1) lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 to the consumer level.
Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 monitor/defibrillators.
Denton Pharma, Inc. dba Northwind Pharmaceuticals, an affiliate of Northwind Pharmaceuticals, LLC (?Northwind?) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300mg, to the consumer level. The recall is in response to the manufacturer?s recall of all un
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, USP (including the 150mg and 300mg strengths). While Mylan has not received any reports of adverse eve
Mavidon is voluntarily recalling all lots of products manufactured at our facility including LemonPrep?, PediaPrep? and Wave Prep 4-ounce tubes and single use cups, Cardio Prep and Collodions, Collodion removers due to contamination with Burkholderia cepacia.
Appco Pharma LLC (Appco) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules to the Consumer level. Ranitidine Hydrochloride Capsules are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA)