FDA MedWatch Safety Alerts

Navajo Heating Pad Recalled for Overheating and Burn Risk

The FDA has identified a Class I recall for Navajo Manufacturing Company's Handy Solutions Neck & Shoulders Heating Pad (Model 25607) due to an overheating and burn risk. The company is removing the affected devices from the market, and consumers are advised to immediately discontinue use, cut the power cord, and dispose of the product.

Amneal Pharmaceuticals Recalls Magnesium Sulfate Due to Product Mix-Up

Amneal Pharmaceuticals LLC is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, due to a product mix-up where a pouch contained an IV bag of Tranexamic Acid. The recall is to the hospital level nationwide. The company has received no adverse event reports related to this recall.

FDA Early Alert: Insulet Omnipod 5 Pods May Not Deliver Insulin

The FDA has issued an Early Alert regarding Insulet Omnipod 5 Pods that may have a tear in internal tubing, potentially leading to under-delivery of insulin and high blood glucose levels. Insulet has issued a voluntary correction recommending affected pods not be used, with 18 serious injuries reported.

FDA Early Alert: Surgical Stapler Issue Linked to Bleeding, Death

The FDA issued an Early Alert regarding a potentially high-risk issue with Intuitive Surgical's 8mm SureForm 30 Gray Reload surgical staplers. The issue has been linked to incomplete staple lines, causing bleeding and resulting in four serious injuries and one death. Affected customers are advised to immediately stop use and quarantine the product.

Integra LifeSciences Convenience Kit Needle Recall

The FDA is alerting the public about a recall initiated by Integra LifeSciences for certain Convenience Kit Needles, specifically the Codman Microsensor Basic Kits and Cerelink ICP Sensor Basic Kits. Affected customers and distributors are instructed to immediately remove these devices from service or distribution.

FDA: Dialysis Tubing Sets Recalled Due to Dislodging, Updated Instructions

The FDA is alerting healthcare providers about a recall of Vantive dialysis tubing sets due to potential dislodging of the deaeration chamber. Updated instructions for use have been issued to mitigate risks, emphasizing monitoring the chamber during therapy. This is a correction and does not involve removing the devices from use or sale.

FDA Early Alert: Erbe USA Cryoprobes Rupture Risk

The FDA issued an Early Alert regarding Erbe USA Flexible Cryoprobes due to a risk of rupture during activation, potentially causing injuries and hearing loss. Erbe USA has recalled affected lots and recommended discontinuing use.

Integra LifeSciences Recalls MediHoney and CVS Wound Dressings

The FDA announced a recall initiated by Integra LifeSciences for certain MediHoney and CVS Wound Gel products due to packaging failures that could lead to infection or delayed care. The recall involves removing affected products from service and distribution. Integra LifeSciences has reported 11 serious injuries related to MediHoney and three related to CVS Wound Gel.

Medline Industries Recalls Catheters Due to Particulates and Infection Risk

The FDA has identified a Medline Industries catheter recall as the most serious type due to potential particulates causing infection or embolism. Affected product lots must be destroyed. This is an expansion of a previous recall.

FDA Safety Communication on Choking Rescue Protocols and Devices

The FDA is issuing a safety communication to encourage the public and healthcare providers to follow established choking rescue protocols before using anti-choking devices. The agency highlights that established protocols, such as back blows and abdominal thrusts, are the most effective method and that using devices first could delay life-saving actions.