🏥 Medical Devices • 15,203 recalls
DePuy Orthopaedics
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure
DePuy Orthopaedics
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.
DePuy Orthopaedics
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
DePuy Orthopaedics
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm endcap not seating flush with the nail while inserting during a procedure.
Abbott Molecular
There is a potential for abnormal (non-sigmoidal) amplification curves.
Abbott Molecular
There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
Abbott Molecular
There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury
Abbott Molecular
There is an issue with the installation of updated camera firmware on the system.
Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available
DiaSorin Molecular
A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.
bioMerieux
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
bioMerieux
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.
bioMerieux
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
bioMerieux
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause fire, electric shock, injury, or damage to Speech Generating Device or other property