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.
FDA MedWatch
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.
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.
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.
BD Announces Voluntary Recall on Intraosseous Products
BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on the BDTM Intraosseous Needle Set Kits, BDTM Intraosseous Manual Driver Kits and BDTM Intraosseous Powered Drivers.
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 the affected lot of the product to contain the bacteria Gluconacetobacter liquefaciens.
FDA Alerts Providers and Patients to Check for Premature Battery Depletion in Certain Medtronic Pacemakers: FDA Safety Communication (UNPUBLISHED)
The FDA is issuing this safety communication to alert health care providers and patients about issues that may cause batteries in certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) to drain more quickly than expected.
FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States: FDA Safety Communication (UNPUBLISHED)
The FDA is warning of risks associated with the use of devices for diabetes management unauthorized for sale in the U.S., whether used alone or along with other devices.
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.
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.
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.
Green Pharmaceuticals Inc Issues Voluntary Nationwide Recall of SnoreStop NasoSpray Due to Microbial Contamination
Camarillo, California, Green Pharmaceuticals Inc is voluntarily recalling lot 2373/21222 of SnoreStop NasoSpray, packaged in 0.3 FL OZ (9ml) bottles to the consumer level. FDA testing found product to contain microbial contamination identified as Providencia rettgeri. This microorganism is rarely as
Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination
Lawrence, Kansas – Plastikon Healthcare, LLC is voluntarily recalling one (1) lot of Milk of Magnesia 2400 mg/10 mL Oral Suspension, one (1) lot of Milk of Magnesia 2400 mg/30 mL Oral Suspension, eleven (11) lots of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL
Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect
Medtronic recalls pump implant kit due to a pump weld defect that may lead to corrosion of pump internal parts and cause the pump to rotate incorrectly.