Infusion Pump Intermittent Connection Issue from Smiths Medical

Breathing circuits may develop cracks during use, potentially causing ventilation leaks that can result in hypoxia or hypercarbia.

Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to Potential for Underinfusion

The Shiley Adult Flexible Tracheostomy Tube is being recalled as it may come loose if the flange disconnects, potentially leading to a blocked airway.

Amneal Pharmaceutical LLC, is recalling three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg to the consumer level as the tablets may exhibit black spots on the tablet surface due to microbial contamination. The observance of black spots was reported in a product quality complaint

False Alarm Issue with Infusion Pump from Smiths Medical

Infusion Pump Intermittent Connection Issue from Smiths Medical

Infusion Pump Thermal Damage Issue from Smiths Medical

FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.

The FDA is warning that patients stopping the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) after long-term use may experience rare but severe itching. These medicines are available in prescription and over-the-counter (OTC) forms. The itching, also called pruritus, has been r

Esophagogastric Tube Recall: BD Issues Correction for Esophagogastric Balloon Tamponade Tubes due to Challenges Removing Plastic Plugs from Rubber Lumen

FOR IMMEDIATE RELEASE – Date: May 21 2025, Nogales, AZ, UMARY USA is voluntarily recalling all lots of Unavy Ácido HIALURÓNICO (30 caplets/850 mg) and Umovy Ácido HIALURÓNICO (30 caplets/850 mg), to the consumer level. FDA laboratory analysis confirmed that these products are tainted with the drug i

The FDA and the CDC are recommending a pause in the use of Ixchiq (Chikungunya Vaccine, Live) in individuals 60 years of age and older while the Agencies investigate postmarketing reports of serious adverse events, including neurologic and cardiac events, in individuals who have received the vaccine

The FDA is alerting consumers, tattoo artists, and retailers of the potential for serious injury from use of tattoo inks that are contaminated with bacteria, including Pseudomonas aeruginosa.

EnShiShiXiangNiShangMaoYouXianGongSi is voluntarily recalling one lot of ENDURANCE BOOST WITH HORNY GOAT WEED (20 Count)

Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss

FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name “Hippo”, which includes “Cheetah”; collectively, the “product