MedWatch Safety Alerts

2024 Safety Communications

Listing of Medical Device 2024 Safety Communications

Wipro GE Healthcare Private Ltd. Recalls Care Plus, Care Plus models 1000-4000 and Lullaby Incubators Due to Problems with Door Latch

Wipro Ge Healthcare Private Ltd. is recalling its Care Plus and Lullaby Incubators because the bedside panel or porthole may not latch properly

Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication

Learn more about recommendations for patients who are considering a Hintermann Series H3 TAR system or who have one; recommendations for health care providers

Follow Instructions for Safe Use of Electrical Operating Room Tables - Letter to Health Care Providers

Problems may occur if electrical operating room table best practices are not followed. Read the FDA’s recommendations to avoid complications

Megadyne Reiterates Intended Use Population Change for Megadyne Mega Soft Universal and Universal Plus Patient Return Electrodes

Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12

2024 Medical Device Recalls

2024 Medical Device Recalls

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

2023 Medical Device Recalls

2023 Medical Device Recalls

Olympus Corporation of the Americas Recalls Bronchofiberscopes and Bronchovideoscopes Because They Can Lead to Burns and Fire

Olympus bronchoscopes, used to examine or treat a person's airways, are being recalled because they can lead to burns and fire

BioZorb Markers and Potential Risks with Use in Breast Tissue: FDA Safety Communication

FDA is informing the public of adverse events reported with the use of BioZorb Marker including pain, migration, erosion, and others

Avanos Medical, Inc. Announces Voluntary Recall in Response to Nurse Assist, LLC Sterile Water Medical Products Recall

In direct response to the Nurse Assist, LLC voluntary recall of pre-filled syringes and other sterile water products, Avanos Medical, Inc. (NYSE: AVNS) voluntarily recalled

Brassica Pharma Pvt. Ltd. Issues Voluntary Nationwide Recall of Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, Lubricant PM Ointment Due to Potential Lack of Sterility

Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with expiration date ranging from February 2024 to September 2025. The products

Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube for Risk of Airway Obstruction

The NIM CONTACT and Standard Reinforced EMG Endotracheal Tubes may obstruct the patient’s airway

Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels: FDA Safety Communication

Do not use smartwatches or smart rings to measure blood glucose. They are not authorized by the FDA. Using them could result in inaccurate blood glucose measurement, which can lead

Update: Recommendations for Certain Medtronic Electromyogram Endotracheal Tubes and Risk of Airway Obstruction – Letter to Health Care Providers

Medtronic initiates recall for silicone-based EMG endotracheal tubes due to the risk of airway obstruction and ventilation failure

Philips Recalls BrightView Imaging Systems Due to the Detector Unexpectedly Falling

If the detector support component fails, imaging cannot be completed, and the detector may contact the patient

Smiths Medical ASD Inc. Recalls Medfusion Model 4000 Syringe Pump Due to Issues Associated with Earlier Software Versions

Smiths Medical recalls Medfusion model 4000 syringe pump due to software issues, impacting the alarm system, pump, control screen, and other components

Percussionaire Recalls High Frequency Transport Phasitron Breathing Circuit Kits for Over-Pressurization

The High Frequency Transport Phasitron Breathing Circuit Kit is used for continuous ventilation of patients. The kits are recalled due to a product defect that causes over-

Today The World Issues Voluntary Nationwide Recall of All Lots of Arize Herbal Dietary Supplement Capsules Due to the Presence of Undeclared Nortadalafil

“Today The World” is voluntarily recalling one lot of Arize Herbal Dietary Supplement capsules to the consumer level. FDA analysis has found the products to contain undeclared

Today The World Issues Voluntary Nationwide Recall of All Lots of Sustain and Schwinnng brand Dietary Supplement Capsules Due to the Presence of Undeclared Tadalafil and Nortadalafil

“Today The World” is voluntarily recalling two lots of Sustain herbal dietary supplement capsules and one lot of Schwinnng capsules to the consumer level. FDA analysis has found

General Information