Complete FDA and NHTSA recall records dated in December 2019.
These records include useful source details for the selected month.
Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips.
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company became aware that the device had been used for…
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during…
The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a limited…
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length
Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
The incorrect outer carton box was used for the product.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
