Search

A textile defect was identified within the body of an Hemagard Knitted Bifurcated Vascular Graft.  This issue has been identified as lot # and serial # specific. Recall start date: June 2, 2023

There is the potential that an incorrect type of secondary latch could have been installed on the northeast (ne) and/or northwest (nw) bedside panels for certain Giraffe Omnibed Carestation devices (serial number specific). With the incorrect type of…

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…

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…

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

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…

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…

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…

Stryker has determined that size 11 (11mm) height peek Ogival Interbody Cage (OIC) was incorrectly laser marked as having a size 10 (10mm) height. Recall start date: May 19, 2023

Currently, the Hemospray instructions for use states "Potential complications: when spraying in the retroflexed position, Hemospray powder may adhere to the outside of the endoscope. This may result in difficulty repositioning / removing the endoscope,…

Health Canada advised that the Philaser Type 2.0 device is considered a class III medical device and requires a licence.  The Philaser Type 2.0 device is not currently licensed, so we have stopped sales and advertisement of the Philaser Type 2.0…