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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.
June 14, 2022 at 12:00 AM
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.
June 10, 2022 at 12:00 AM
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.
June 10, 2022 at 12:00 AM
The FDA is issuing this letter to ensure you are aware of this defect and the recommended actions to take to manage the care of patients currently implanted with a Medtronic HVAD system.
June 09, 2022 at 12:00 AM
Woodside Acquisitions Inc. recalls COVID-19 Rapid Test Kits because they are not authorized, cleared, or approved by the FDA.
June 09, 2022 at 12:00 AM
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
June 08, 2022 at 12:00 AM
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
June 08, 2022 at 12:00 AM
The iCast catheter-placed stent supports the walls of structure within the body. The balloon or catheter hub may separate during removal, causing harm to the patient.
June 07, 2022 at 12:00 AM
Nottingham, NH, Buzzagogo Inc. is voluntarily recalling one lot of Allergy Bee Gone for Kids Nasal Swab Remedy to the consumer level due to potential microbial contamination. FDA testing found some product to contain elevated levels of yeast & mold and may contain the bacteria Bacillus cereus.