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MedWatch Safety Alerts

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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.
Author: FDA
Posted: March 4, 2021, 5:00 am
The FDA is alerting consumers, health care providers and users that improper use of thermal imaging devices may provide inaccurate temperature readings.
Author: FDA
Posted: March 4, 2021, 5:00 am
The HeartWare HVAD system pump is used in patients with heart failure. Some pumps had delayed or failed restarts, which may cause serious risk to patients.
Author: FDA
Posted: March 1, 2021, 5:00 am
List of Medical Device recalls in 2021.
Author: FDA
Posted: March 1, 2021, 5:00 am
Medtronic plc , the global leader in medical technology, has voluntarily issued a global recall of unused Medtronic Valiant Navion™ thoracic stent graft system and informed physicians to immediately cease use of the device until further notice.
Author: FDA
Posted: February 23, 2021, 5:00 am
The Liko Multirall 200 Overhead Lift is a general-purpose lift to move patients from room to room.
Author: FDA
Posted: February 22, 2021, 5:00 am
EMBLEM S-ICD is an implantable defibrillator. In some devices, moisture may get inside and keep the device from shocking the heart to fix heart rhythm.
Author: FDA
Posted: February 19, 2021, 5:00 am
The FDA is informing patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy that must be considered.
Author: FDA
Posted: February 19, 2021, 5:00 am
Adamssecret.co is voluntarily recalling all lots within expiry of Adam’s Secret Extra Strength 1500 and Adam’s Secret Extra Strength 3000 capsules to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil and/or tadalafi
Author: FDA
Posted: February 16, 2021, 5:00 am
EMBLEM S-ICD Subcutaneous Electrode (Model 3501) is part of the Boston Scientific S-ICD System that helps detect heart activity and provides defibrillation therapy.
Author: FDA
Posted: February 10, 2021, 5:00 am
Medfusion 3500 and 4000 syringe pumps control fluid and drug delivery to patients. A software issue may cause over- or under- delivery, causing adverse events.
Author: FDA
Posted: February 10, 2021, 5:00 am
The FDA is informing that recent literature indicates that certain features are associated with better performance.
Author: FDA
Posted: February 9, 2021, 5:00 am
The FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to tumor necrosis factor (TNF) inhibitors.
Author: FDA
Posted: February 4, 2021, 2:00 pm
Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin Sodium Injection, USP to consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL stre
Author: FDA
Posted: February 3, 2021, 5:00 am
Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious injury while used for removing clots in stroke patients
Author: FDA
Posted: January 29, 2021, 5:00 am
The device is used in patients experiencing a stroke. The distal tip may become damaged, which may result in serious injury or death.
Author: FDA
Posted: January 29, 2021, 5:00 am
Wahl Clipper Corporation is voluntarily recalling all Deluxe Heat Therapy Massagers, Model 4212.
Author: FDA
Posted: January 28, 2021, 5:00 am
Meitheal Pharmaceuticals, Inc. (“Meitheal”), announced today that it is voluntarily recalling one (1) lot of Cisatracurium Besylate Injection, USP 10mg per 5mL to the user level. The decision to recall the product was made after a product complaint revealed that a portion of Lot C11507A of cartons l
Author: FDA
Posted: January 27, 2021, 5:00 am
Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to con
Author: FDA
Posted: January 25, 2021, 5:00 am
Boston Scientific Corporation (NYSE: BSX) has announced it has initiated a global, voluntary recall of all unused inventory of the LOTUS Edge™ Aortic Valve System due to complexities associated with the product delivery system. The voluntary recall is related solely to the delivery system, as the va
Author: FDA
Posted: January 11, 2021, 5:00 am