Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-08-14FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIIngenuity CT, Model # 728326, computed tomography x-ray system
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
- 2019-08-14FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- 2019-08-14FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- 2019-08-14FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- 2019-08-14FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS 4600 Chemistry System, clinical chemistry analyzer
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- 2019-08-14FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS 4600 Chemistry System, clinical chemistry analyzer
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- 2019-08-14FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS 5600 Integrated System, clinical chemistry analyzer
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- 2019-08-14FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS 5600 Integrated System, clinical chemistry analyzer
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- 2019-08-14FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- 2019-08-14FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS 350 Chemistry System, clinical chemistry analyzer
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- 2019-08-14FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS 250AT Chemistry System, clinical chemistry analyzer
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- 2019-08-14FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS 250 Chemistry System, clinical chemistry analyzer
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- 2019-08-14FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS 250 Chemistry System, clinical chemistry analyzer
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- 2019-08-14FDA-DeviceCenturion Medical Products CorporationClass IISNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for laceration repairs for general population.
Potential for sterile packaging to be compromised
- 2019-08-14FDA-DeviceCenturion Medical Products CorporationClass IILACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceration repairs for general population.
Potential for sterile packaging to be compromised
- 2019-08-14FDA-DeviceCenturion Medical Products CorporationClass IIUNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional anesthesia nerve blocks for general population.
Potential for sterile packaging to be compromised
- 2019-08-14FDA-DeviceCenturion Medical Products CorporationClass IIDRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
Potential for sterile packaging to be compromised
- 2019-08-14FDA-DeviceCenturion Medical Products CorporationClass IIDRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
Potential for sterile packaging to be compromised
- 2019-08-14FDA-DeviceCenturion Medical Products CorporationClass IIHIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
Potential for sterile packaging to be compromised
- 2019-08-14FDA-DeviceCenturion Medical Products CorporationClass IIDAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
Potential for sterile packaging to be compromised
- 2019-08-14FDA-DeviceCenturion Medical Products CorporationClass IILVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.
Potential for sterile packaging to be compromised
- 2019-08-14FDA-DeviceCenturion Medical Products CorporationClass IINEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line Insertion procedures on newborns.
Potential for sterile packaging to be compromised
- 2019-08-14FDA-DeviceCenturion Medical Products CorporationClass IICIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns.
Potential for sterile packaging to be compromised
- 2019-08-14FDA-DeviceCenturion Medical Products CorporationClass IICIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performing circumcision procedures on newborns.
Potential for sterile packaging to be compromised
- 2019-08-14FDA-DeviceCenturion Medical Products CorporationClass IISTERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used for arthrogram injection and aspiration. The kits are used in the diagnostic section of the radiology department, by medical professionals in a clinical setting.
Potential for sterile packaging to be compromised
- 2019-08-14FDA-DeviceCenturion Medical Products CorporationClass IISTERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facilitate examination. It is used by medical professionals in a clinical setting.
Potential for sterile packaging to be compromised
- 2019-08-14FDA-DeviceHowmedica Osteonics Corp.Class IISerrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.
- 2019-08-14FDA-DeviceDRG Instruments GmbHClass IIDRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means
Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed significantly lower
- 2019-08-14FDA-DevicePolymer Technology Systems, Inc.Class IIIHenry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus ana
The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
- 2019-08-14FDA-DevicePolymer Technology Systems, Inc.Class IIIPTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A ME
The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
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