MedWatch Safety Alerts

Belviq, Belviq XR (lorcaserin) by Eisai: Drug Safety Communication - FDA Requests Withdrawal of Weight-Loss Drug

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

2020 Medical Device Recalls

List of Medical Device recalls in 2020

Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing

Missing or broken retainer ring could cause under or over delivery of insulin. This may cause patient injury or death

GE Healthcare Recalls Carestation 600 Series Anesthesia Systems Due to Loss of Mechanical Ventilation

A loose cable connection could cause the loss of mechanical ventilation which could lead to serious injury or death

GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Incorrect Oxygen Values

A manufacturing problem could cause the displayed oxygen values to be incorrect which could lead to serious injury or death

Efficient Laboratories, Inc. Issues Voluntary Nationwide Recall of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX due to Microbial Contamination

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

Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication

Regarding cybersecurity vulnerabilities identified in a wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers

Clozaril, Fazaclo ODT, Versacloz (clozapine): Drug Safety Communication - FDA Strengthens Warning That Untreated Constipation Can Lead to Serious Bowel Problems

FDA is strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, uncommonly, progress to

Distributor Teleflex Recalls the Galemed Babi.Plus Pressure Relief Manifolds Due to Dislodged Valve

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

King Systems Issues Recall of King Vision Video Laryngoscope Video Adapter Size 1/2

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

2020 Safety Communications

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

Cybersecurity Vulnerabilities in Certain GE Healthcare Clinical Information Central Stations and Telemetry Servers: Safety Communication

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

The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

FDA is sharing recommendations and updates to help improve duodenoscope reprocessing

Surgical Gowns and Packs by Cardinal Health: FDA Statement - Potential Quality Issues Affecting Some of its Level 3 Surgical Gowns and Accompanying PreSource Procedural Packs

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

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility

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

Belviq, Belviq XR (lorcaserin): Drug Safety Communication - Due to Possible Increased Risk of Cancer

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 (

Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles

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

Stryker Launches Voluntary Field Action for Specific Units of The LIFEPAK® 15 Monitor/Defibrillator

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 Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

Denton Pharma, Inc. dba Northwind Pharmaceuticals, an affiliate of Northwind Pharmaceuticals, LLC (“Northwind”) today announced the voluntary recall of all unexpired lots of

Mavidon Issues Voluntary Worldwide Recall of Manufactured Products Including Lemonprep® Tubes And Single Use Cups Pediaprep® Tubes And Single Use Cups Wave Prep® Tubes And Single Use Cups Cardio Prep Single Use Cups Due To Burkholderia Cepacia Contamination

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

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