Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial used with SmartDrive MX2+ Wheelchair Power Assist system may be unresponsive to users.

Biosense Webster updated Instructions for Use for Varipulse due to higher-than-anticipated incidence of peri-procedural stroke or transient ischemic attack.

Philips Allura and Azurion interventional fluoroscopy systems are used in operating rooms. Incorrectly positioned mattresses may cause patient falls and injuries.

ROi newborn kits include Neo-Tee T-Piece Resuscitators. The Neo-Tee may have an undersized controller spring that could affect patient breathing support.

Olympus Guide Sheath Kits collect samples from breathing organs through an endoscope. The tip of the guide sheath may detach during a procedure.

February 25, 2025 – Natural Dior LLC, is voluntarily recalling the affected lots of Vitafer-L Gold Liquid, a dietary supplement with iron and vitamins, to the consumer level. The product has been found to contain undeclared tadalafil, an ingredient in FDA approved products for treatment of male erec

February 24, 2025 – Bethlehem, PA. Central Admixture Pharmacy is recalling three lots of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags (NDC: 71285-6092-1) to the hospital level. The product is being recalled because CAPS was notified by their raw material supplier of

02/25/2025 Melville, NY. Ascent Consumer Products Inc. is voluntarily recalling one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System to the consumer level. The recall is being initiated due to a confirmed test result of microbial contamination of the product with Staphylococcus aureus (S

Boston Scientific is recalling pacemakers due to a manufacturing issue that may cause early device replacement.

Benton, Arkansas – 02/2019/2025 –One Source Nutrition is voluntarily recalling all lots of Vitality capsules to the Consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which are ingredients in FDA approved products for treatment of male erectile dysfunctio

BD (Becton, Dickinson and Company) today announced the voluntary recall of one lot of ChloraPrep™ Clear 1 mL Applicators due to fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides

Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk That the Tip of Guidewires or Other Medical Devices May Come into Contact with The Impella Pump During Insertion, Adjustment, Or Removal

ICU Medical, Inc. is voluntarily recalling one lot each of POTASSIUM CHLORIDE Inj. bags with overwrap labels 10mEq, packaged in cases of POTASSIUM CHLORIDE Inj. 20 mEq, to the user level. ICU medical has received a customer complaint which states that bags of POTASSIUM CHLORIDE Inj. 20 mEq have inco

Phasitron Breathing Circuits support continuous ventilation. A malfunctioning venturi component in the circuit may cause reduced oxygen flow.

Medline Integrated Arterial Catheters continuously monitor blood pressure. Excess material on the catheter hub that may detach and enter the patient.

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

JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD is recalling certain devices due to incidents of device melting and fire during the use of oxygen concentrators.

The FDA is alerting users of diabetes-related medical devices that smartphones connected to diabetes devices may fail to send critical safety alerts.

Baxter Healthcare is recalling the Life2000 Ventilator System by correction, due to a defective battery charger making the ventilator inoperable.

Becker and Exacta EDMS are used for draining and monitoring cerebrospinal fluid in the brain. Stopcocks may have cracks or leaks that pose a risk to patients.