🏥 Medical Devices • 4,262 recalls
Baxter Healthcare
Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).
DePuy Mitek, Inc., a Johnson & Johnson
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
Philips Electronics North America
Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable to perform patient discharge and transfer operations. Any subsequent attempt to perform these operations will cause the station to restart, resulting in a short period of loss of monitoring at the Surveillance station during such restart. Until this issue can be corrected, users should avoid intentionally restarting their Surveillance stations in 2018.
Circulatory Technology
The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.
Zevex Incorporated (dba Moog Medical Medical Devices Group)
Particulate found on the Curlin spike.
The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time.
Zevex Incorporated (dba Moog Medical Medical Devices Group)
Particulate found on the Curlin spike.
It the WiFi connection between the SkyPlate detector and HP transfer point is weak, an image may fail to transfer from the SkyPlate detector to the system. The image remains in the memory of the detector, but cannot be transferred wirelessly or by use of the backup cable. To continue, the operator can reset the SkyPlate detector by removing its batteries, but the acquired image is lost and a re-take is necessary.
Zevex Incorporated (dba Moog Medical Medical Devices Group)
Particulate found on the Curlin spike.
Circulatory Technology
The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.
Zevex Incorporated (dba Moog Medical Medical Devices Group)
Particulate found on the Curlin spike.
Fresenius Medical Care Renal Therapies Group
While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly.
Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.
Two specific lots was incorrectly manufactured containing a UK power adapter.
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production.
The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.
The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.
The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.
Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production.