95,064 total recalls in our database
Cook Medical Incorporated
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021.
Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes. When printing consecutively numbered tube labels using this optional Barcode Counter function, the system incorrectly converts numbers with consecutive multiple zeroes in the middle, potentially leading to wrong barcode IDs. The firm reports that this does not affect automated label creation or reprinting of individual labels and that no other system functions are affected.
The firm has identified customer sites where there are modules on which the safety pacemaker label is missing. The information regarding the label included in the Operations Manual has been updated to specify that: 1) the risk of a pacemaker malfunction applies to anyone with a pacemaker who may work on these modules; and 2) the minimum safety distance has been increased to 200 mm (7.87") from the transport mechanisms. Any person with a pacemaker must not get closer than this distance from the modules axes.
Cook Medical Incorporated
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured.
The product is labeled with an incorrect expiration date.
Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 ¿g/dL). Results for patient testing with this lot will be displayed as HIGH.
Kubota Manufacturing of America Corporation, of Gainesville, Ga.
Hot coolant can spray out onto consumers from the overheated and pressurized coolant reservoir tank, posing a burn hazard.
Unknown Manufacturer
The side handle sold with the drill can slip or break, leading to a loss of control of the tool, posing an injury hazard
Unknown Manufacturer
The mirror can detach from the medicine cabinet door, posing a laceration hazard to consumers.
Ridge Properties
The packaging is not child resistant as required by the Poison Prevention Packaging Act. The pain and itch relief creams, sprays and gels contain lidocaine, posing a risk of poisoning to young children if they put it on their skin or ingest it.
McCain Foods USA
During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted.
During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted.
McCain Foods USA
During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted.
McCain Foods USA
During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted.
During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted.
McCain Foods USA
During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted.
McCain Foods USA
During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted.
McCain Foods USA
During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted.