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Olympus is taking this recall action after investigating reported complaints about issues inflating, deflating and/or retrieving the devices, as well as reports of bursting and leaking. Olympus has received reported adverse events involving foreign body…

Baxter Corporation is issuing an urgent medical device recall for the Amia Automated Peritoneal Dialysis (APD) cycler set listed due to an increase in complaints related to failure alarms for wet cassette integrity test occurring on the Amia devices.…

Our recent interference testing has shown that the presence of lubricants in the vaginal specimen may interfere with the prom test result, which deviates from what is presented in the instructions for use. The defectiveness was discovered 2023-11-08.…

The impurity free salicylic acid is out of specification in the affected batches.

In June 2023, due to market disruptions outside of our control, Cardinal Health changed the supplier for the cotton used to manufactur Webril™ Undercast Padding. Although the Webril™ Cotton Undercast Padding continues to meet product specifications,…

The quality issue under investigation is applicable to the "connection cable venous probe, l0.23m".  The part causing the nonconformance under investigation is responsible for data transmission between the Cardiohelp-i and the venous probe. A…

Smiths Medical has identified a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the device's o-ring may be oversized affecting seal integrity. Recall Start Date: November 9, 2023

Baxter is issuing an important product information letter to communicate that the cardiovascular surgery marketing brochure (Ref ca-as32-210022 (English) and ca-as32-220004 (French)) that was distributed for the products listed above contains inaccurate…

It has been determined that the terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed. Because of this, the cable became disconnected, and arcing occurred. Melting of the cable due to…

Baxter is issuing an important product information letter to communicate that the cardiovascular surgery marketing brochure (Ref ca-as32-210022 (English) and ca-as32-220004 (French)) that was distributed for the products listed above contains inaccurate…

Baxter is issuing an important product information letter to communicate that the cardiovascular surgery marketing brochure (Ref ca-as32-210022 (English) and ca-as32-220004 (French)) that was distributed for the products listed above contains inaccurate…

Philips has been informed of an event in which the structural integrity of the Panorama 1.0T HFO system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. During a quench, a large amount of helium…

Product sold without market authorization (DIN) Canada. Product contains undeclared pancreatin that is listed on the Prescription Drug List (provides more than 20 000 USP units of lipase activity/dose).

BD continues to receive complaints for the product regarding mismatch between the coaxial and the needle in mission kit devices.  Based on the event reported, the internal diameter of the coaxial cannula may be smaller or larger than the external…

Medtronic has received 87 complaints as of October 5th, 2023 indicating potential health hazards of degraded or loss of functionality of the device with specific lots. The potential hazards can cause unintended extubation, a delay or a cancelation of the…