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July 01, 2022 at 12:00 AM
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 infant formula products.
June 30, 2022 at 12:00 AM
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.
June 30, 2022 at 12:00 AM
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 mammograms.
June 30, 2022 at 12:00 AM
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 analysis undertaken at the request of Loud Muscle Science, LLC found the products to be tainted with tadalafil, an ingredient i
June 30, 2022 at 12:00 AM
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.
June 30, 2022 at 12:00 AM
Listing of Medical Device 2022 Safety Communications
June 30, 2022 at 12:00 AM
Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication
June 29, 2022 at 12:00 AM
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 Morphine Sulfate 60 mg Extended-Release tablets (Comprised of 10 bottles) to the consumer level listed in the table below. The
June 28, 2022 at 12:00 AM
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.
June 28, 2022 at 12:00 AM
List of Medical Device recalls in 2022.
June 28, 2022 at 12:00 AM
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.
June 28, 2022 at 12:00 AM
Listing of Medical Device 2022 Safety Communications
June 23, 2022 at 12:00 AM
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.
June 23, 2022 at 12:00 AM
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.
June 23, 2022 at 12:00 AM
List of Medical Device recalls in 2022.
June 22, 2022 at 12:00 AM
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.
June 22, 2022 at 12:00 AM
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 Kits and BDTM Intraosseous Powered Drivers.
June 21, 2022 at 10:55 AM
UPDATE on Type III Endoleaks Associated with Endovascular Graft Systems
June 21, 2022 at 12:43 AM
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.
June 21, 2022 at 12:19 AM
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.
June 21, 2022 at 12:00 AM
SafeStar 55 Breathing System Filters reduce contaminants to ventilated patients. A defective lot may have obstructions that keep patients from getting oxygen.
June 21, 2022 at 12:00 AM
The FDA is informing patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy that must be considered.
June 21, 2022 at 12:00 AM
List of Medical Device recalls in 2022.
June 21, 2022 at 12:00 AM
Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication
June 14, 2022 at 12:00 AM
The FDA provides updated information from our ongoing evaluation of NTM infections in patients who have had cardiothoracic surgery using heater-cooler devices.