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

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.

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.

Equinoxe Shoulder Systems were packaged in defective bags. Potential risks including premature implant wear or failure, which may lead to additional surgery.

ROi CPS, LLC recalls Regard Operative Lap P&S Surgical Kit due to sterility concerns. Kits contain a Cardinal Health item linked to Nurse Assist, LLC's recall.

Fresenius Kabi is recalling the Ivenix Large Volume Pump (LVP) for mechanical issues causing the internal Fluid Valve Pins not to move correctly.

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's preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions.

ResMed Ltd. recalls AirFit & AirTouch masks due to possible magnetic interference with certain medical devices. ResMed is updating the labels for safer use.

Busse Hospital Disposables is recalling their Tracheostomy Care Trays and sets in response to Nurse Assist’s November saline recall due to sterility concerns.

The FDA posts letters to health care providers about the safe use of medical devices.

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.

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.

January 5, 2024 – Englewood, Colorado, Leiters Health is voluntarily recalling 33 lots of products listed below to the user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being recalled due to the potential for superpotency because they may contain

Omnipod 5 App recalled due to a software error which occurs when users input bolus amounts below 1 unit without adding a zero before the decimal point.

2024 Medical Device Recalls

On December 13, 2023, Getinge / Atrium Medical Corporation notified affected customers of a nationwide recall (medical device correction) for certain Atrium Express Dry Suction Dry Seal Chest Drains in response to a voluntary medical device recall initiated by a supplier, Nurse Assist. On November

Listing of Medical Device 2024 Safety Communications

This device has significantly changed since FDA authorization, and the safety and effectiveness of the modified device has not been established.