# MedWatch Safety Alerts RSS Feed

- Globus Medical, Inc. Recalls ExcelsiusGPS Flat Panel Fluoroscopy Registration Fixture Due to a Calibration Error Globus Medical, Inc. is recalling the ExcelsiusGPS, an imaging device, due to a calibration algorithm error that may affect the accuracy of implant placement.
- 2024 Medical Device Recalls 2024 Medical Device Recalls
- ResMed Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with Magnets due to Possible Magnetic Interference with Certain Medical Devices ResMed Ltd. recalls AirFit &amp; AirTouch masks due to possible magnetic interference with certain medical devices. ResMed is updating the labels for safer use.
- Neptune Resources, LLC Issues Voluntary Nationwide Recall of Neptune’s Fix Neptune Resources, LLC is voluntarily recalling All lots of Neptune&#039;s Fix Elixir, Neptune&#039;s Fix Extra Strength Elixir, and Neptune&#039;s Fix Tablets to the consumer level. Neptune Resources LLC&#039;s distribution channels have not reported any adverse events from the use of its products. The products are be
- Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg Due to a Mislabeled Package During Manufacturing Woburn, Massachusetts, Azurity Pharmaceuticals, Inc. is voluntarily recalling one (1) lot (F230169A) of Zenzedi® CII (dextroamphetamine sulfate tablets, USP) 30 mg to the consumer level. The product is being recalled due to a report from a pharmacist in Nebraska who opened a bottle of Zenzedi® 30 m
- Haleon Issues Voluntary Nationwide Recall of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult Products Due to Microbial Contamination Haleon is voluntarily recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult to the consumer level. The product is being recalled due to microbial contamination. In immunocompromised individuals, the use of the affected product could potentially result
- Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist: FDA Safety Communication Nurse Assist, LLC announced a recall because the products may not be sterile. Patients are at risk of infection.
- Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Nurse Assist Sterile Saline Placed Into the Following Kits; AMS10833 Local Lower Extremity Pack I, AMS12947 In House Ocular Pack, AMS12947A In House Ocular Pack and AMS13043 Closure Kit On December 22, 2023, Aligned Medical Solutions, Billings, MT, initiated a nationwide recall of Nurse Assist Sterile Saline packaged into medical device kits including AMS10833 Local Lower Extremity Pack I, AMS12947 In House Ocular Pack, AMS12947A In House Ocular Pack and AMS13043 Closure Kit. Produ
- Kilitch Healthcare India Limited Issues Amendments in Last Voluntary Nationwide Recall Press Release Mumbai, Maharashtra, Kilitch Healthcare India Limited is issuing an amendment in the last Nationwide press release dated November 13, 2023 issued for nationwide recall of various eye drops. There are corrections in product NDC No for the below mentioned products. These products were distributed nati
- Prolia (denosumab): Drug Safety Communication - FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease Taking Osteoporosis Medicine Prolia (Denosumab): FDA Safety Communication.
- 2024 Safety Communications Listing of Medical Device 2024 Safety Communications
- Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication Recalled masks have magnets that can cause injuries or death when the mask is near certain implanted metallic medical devices or metallic objects in the body.
- ROi CPS, LLC Recalls Regard Operative Lap P&S Surgical Kit Due to Possible Lack of Sterility ROi CPS, LLC recalls Regard Operative Lap P&amp;S Surgical Kit due to sterility concerns. Kits contain a Cardinal Health item linked to Nurse Assist, LLC&#039;s recall.
- Megadyne Medical Products, Inc. Recalls Mega Soft Universal Patient Return Electrode Due to Reports of Patient Burns Megadyne is updating the instructions and product labeling to reflect that the Mega Soft Universal pads should not be used in patients under 12 years old.
- Risks with Exactech Equinoxe Shoulder System with Defective Packaging - FDA Safety Communication Equinoxe Shoulder Systems were packaged in defective bags. Potential risks including premature implant wear or failure, which may lead to additional surgery.
- Fresenius Kabi USA, LLC Recalls Ivenix Large Volume Pump (LVP) of the Ivenix Infusion System Due to Mechanical Interference Fresenius Kabi is recalling the Ivenix Large Volume Pump (LVP) for mechanical issues causing the internal Fluid Valve Pins not to move correctly.
- Certain Type of Medicines Approved for Type 2 Diabetes and Obesity: Drug Safety Communication - Update on FDA’s Ongoing Evaluation of Reports of Suicidal Thoughts or Actions The FDA has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 receptor agonists. FDA&#039;s preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions.
- Busse Hospital Disposables, Inc. Recalls Care Trays and Kits Containing Sterile Water Based Products Under Recall by Nurse Assist Busse Hospital Disposables is recalling their Tracheostomy Care Trays and sets in response to Nurse Assist’s November saline recall due to sterility concerns.
- 2024 Letters to Health Care Providers The FDA posts letters to health care providers about the safe use of medical devices.
- Potential Exposure to Certain Chemicals with Use of GE HealthCare EVair and EVair03 Compressors with Certain Ventilators – Letter to Health Care Providers FDA issues a letter to health care providers on potential exposure to certain chemicals with use of GE HealthCare EVair and EVair03 compressors with certain  ventilators.