All Recalls

95,018 total recalls in our database

Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.

Apr 18, 2024 Diagnostic Equipment Nationwide View Details →

Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.

Dec 8, 2023 Other Medical Devices Nationwide View Details →

The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting causing the app to receive alerts for all pending alarm notifications and other events when the app restarts, experience difficulty in placing and maintaining staff-to-staff phone calls, and frequently appears offline while the app restarts.

Apr 11, 2024 Other Medical Devices Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.

Apr 22, 2024 Surgical Instruments Nationwide View Details →

Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.

May 9, 2024 Other Medical Devices Nationwide View Details →