MedWatch Safety Alerts

Information Regarding Medically Necessary Specialty Infant Formulas: Notice to Health Care Providers

The FDA is providing information to health care professionals to help their patients obtain access to medically necessary specialty formulas, the amino acid-based and the metabolic

Copiktra (duvelisib): Drug Safety Communication - FDA Warns about Possible Increased Risk of Death and Serious Side Effects

FDA is warning that results from a clinical trial show a possible increased risk of death with Copiktra (duvelisib) compared to another medicine to treat a chronic blood cancer. <

Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication

The FDA is alerting patients who had mammograms at Capitol Radiology, LLC in Laurel, Maryland, on or after June 26, 2018, about possible problems with the quality of their

Update: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication

The FDA is alerting patients who had mammograms at Capitol Radiology, LLC on or after June 26, 2018, about possible problems with the quality of mammograms

Loud Muscle Science, LLC Issues Voluntary Recall of Launch Sequence Capsules Due to the Presence of Undeclared Tadalafil in United States and Canada

Hauppauge, NY, Loud Muscle Science, LLC is voluntarily recalling the following Launch Sequence products and lots listed in the table below to the consumer level. Laboratory

2022 Safety Communications

Listing of Medical Device 2022 Safety Communications

Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

Bryant Ranch Prepack Inc. Issues Voluntary Nationwide Recall of Morphine Sulfate 30 mg Extended Release and Morphine Sulfate 60 mg Extended-Release Due to Label-Mix Up

Burbank, California, Bryant Ranch Prepack Inc. is voluntarily recalling one lot of Morphine Sulfate 30 mg Extended-Release tablets (Comprised of 10 bottles), and one lot of

Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication

The FDA is warning health care providers, parents and caregivers that there is a risk of death or injury in babies who use neck floats

2022 Medical Device Recalls

List of Medical Device recalls in 2022

GE Healthcare Recalls CARESCAPE R860 Ventilator Due to Early Failure of Backup Batteries that May Cause Unexpected Ventilator Shut Down

If a CARESCAPE R860 ventilator is running on backup batteries and the battery fails, the ventilator may suddenly shut down and stop supporting the patient

Baxter Healthcare Corporation Recalls Volara System For Risk Of Respiratory Distress In Ventilated Patients During Home Use

When the Volara system’s in-line ventilator adaptor is used at home with a ventilator, it may prevent the patient from getting enough oxygen

Medtronic Recalls HeartWare HVAD System Batteries Due to Battery Failure

The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging

Vi-Jon, LLC Issues Voluntary Nationwide Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination

Vi-Jon, LLC is voluntarily recalling 1 (one) lot of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) to the consumer level. Testing identified

BD Announces Voluntary Recall on Intraosseous Products

BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on the BD Intraosseous Needle Set Kits, BD Intraosseous Manual Driver

UPDATE on Type III Endoleaks Associated with Endovascular Graft Systems – Letter to Health Care Providers

UPDATE on Type III Endoleaks Associated with Endovascular Graft Systems

Draeger, Inc Recalls SafeStar 55 Breathing System Filters for Possible Obstructions That May Block Oxygen Flow To Patients

SafeStar 55 Breathing System Filters reduce contaminants to ventilated patients. A defective lot may have obstructions that keep patients from getting oxygen

Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

The FDA is informing patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy that must be considered

Latin Foods Market Issues Voluntary Nationwide Recall of Artri King Reforzado Con Ortiga Y Omega 3 Due to the Presence of Undeclared Diclofenac and Dexamethasone

Latin Foods Market is voluntarily recalling one lot, LOTE 334 21, of Artri King Reforzado con Ortiga y Omega 3 tablets to the consumer level

UPDATE: Potential Risk of Infection When Using Heater-Cooler Devices – Letter to Health Care Providers

The FDA provides updated information from our ongoing evaluation of NTM infections in patients who have had cardiothoracic surgery using heater-cooler devices

General Information