95,083 total recalls in our database
Zimmer Biomet
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
BD LIFE SCIENCES
The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Open System Reagent (OSR) customers utilizing User Defined Protocol (UDP) assays. Customers utilizing only IVD assays are not affected. This anomaly may cause the OSR customer system to incorrectly switch the columns of the truth table on the users display. If the user tries to fix their display data, the display will appear correct however, the database may become incorrect, potentially resulting in incorrect results reporting. BD is able to trace the issue to a limited number of instruments that have software version 4.44A installed. Note that the problem only affects customers that are either creating a new UDP with Result Logic or modifying the Result Logic of an existing UDP.
Beckman Coulter
Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.
Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of their mounting sleeves that may allow the patient to contact the underlying carbon fiber structure of the Wilson frame and could lead to a pressure injury.
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Bd Diagnostic
BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease, results approach the assay cutoff threshold which has the potential to impact test results.
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
Smith & Nephew
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Ion Beam Applications S.A.
In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
Instradent USA
During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Intraoral Scan body is not compatible with the platform diameter of CM Implants when the implant is intraosseoussly (subcrestally) positioned.
Teleflex Medical
Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.
Ace Surgical Supply Co.
Incorrect device was packaged.
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Customer reports of the device handset continuing to operate after release of the activation button.
Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)).
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Ferno-Washington
The recall was initiated as a result of the detection of an incorrect nut used in manufacturing.
Siemens Medical Solutions USA
Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until the next reactivation. Following reactivation, the system no longer initializes as intended.