95,025 total recalls in our database
Perrigo Company PLC
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
CGMP Deviations: failed stability results, inadequate laboratory investigations,
The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.
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
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.
Nikkiso Ltd - Shizuoka Plant
Device lacks premarket approval.
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation
The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when stored at room temperature. Ongoing stability studies have indicated the need to shorten the life of the RPC Buffer once resuspended from the current instruction of one week to two days when stored at room temperature (15degC-30degC).
Abbott Molecular
There is a potential for abnormal (non-sigmoidal) amplification curves.
The dosage information on the pouch is incorrect; the primary carton label is correct.
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.
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
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
Siemens Healthcare Diagnostics
(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expiration date leading to potential erroneous patient sample results
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
There have been reports of stent migration.