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Beckman Coulter has confirmed that specific diluent lot numbers showed that conductivity, osmolality, and ph were out of manufacturing specifications. Quality control results may fail to flag for the affected parameters. Not all diluent containers within…

IDHIFA failed to demonstrate improved OS in adult patients with late stage AML and an IDH2 mutation versus conventional care regimens in a Phase 3 confirmatory study evaluating efficacy and safety. Do not initiate IDHIFA in new patients. IDHIFA is…

The update provides a network isolator for the lan connection, which must be installed in the Mira Max vf10 systems. The isolator is a measure of operator protection. Recall start date: May 29, 2023

Based on an internal investigation, Integra Lifesciences has identified issues with in-process and finished goods endotoxin testing that may result in out of specification endotoxin results. Accordingly, we are recalling those products per the…

Teleflex has initiated a voluntary recall due to reports of disconnection of the 15mm connector from the endotracheal tube (et tube) for the affected products. Recall start date: May 26, 2023

Stryker has identified that the base leg assembly may bend. Bent base leg assembly may result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or erratic or…

Baxter Corporation is issuing an urgent medical device correction due to a defect in the Dose IQ Safety Software used with Novum IQ Large Volume Pump, resulting in an invalid initial setting for the air-in-line threshold for any new care area created in…

Software versions prior to 2.04 show a waveform while in suspend processing, while software version 2.04 and above do not show a waveform. Both software versions show an error message stating "ECG processing suspended" in the waveform zone, "?" in the…

Baxter Corporation is issuing an urgent medical device correction for the Voalte Patient Safety, previously branded as Navicare Patient Safety, software versions 3.9.200 through 4.0.401. Baxter identified a potential risk where the "safety" monitoring…

Ortho™ Sera Papain is used to enhance reactivity of Ortho™ Sera red blood cell antigen typing reagents and red blood cells when used in in-vitro immunohematology assays. Through a customer complaint investigation, the reactivity of Ortho™ Sera Papain of…

Philips has become aware of a software login issue associated with specific models of Mobilediagnost wDR systems running on Windows 10 operating system preventing use of the system. This issue occurred because the software certificate protecting the…

Affected lot(s) may contain the presence of Burkholderia contamination. 

Biomerieux identified a manufacturing event that may contribute to elevated rates of false negative results while using the Biofire RP2.1 panel. Biomerieux has not received any false negative complaints from the field but, out of an abundance of caution…

Baxter Corporation is issuing an urgent medical device recall for the Allen Advance Chest Support to inform customers of the potential for the device to crack where the chest base and prone supports attach to the carbon fiber operating room (or) table…

Nestlé Health Science is recalling twelve lots of Nature’s Bounty Kids Multivitamin Gummies (NPN 80117143) because the product’s label does not indicate that the gummies should not be given to children under four years of age. Giving these products to…