Complete FDA and NHTSA recall records dated in May 2020.
These records include useful source details for the selected month.
Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If…
Failure to prime due to an assembly error
Saline Flush Syringe compromised sterility due to holes in the packaging.
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an…
Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an…
Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305…
Failure to prime due to an assembly error
A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of…
When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.
Inability for the guidewire to pass through the needles included with the catheter kits.
DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging.
Saline Flush Syringe compromised sterility due to holes in the packaging.
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an…
The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health…
Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305…
The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health…
Critical Control Point (CCP) deviation associated with wash process, low levels of chlorine wash, affected product was sent to distribution chain.
Critical Control Point (CCP) deviation associated with wash process, low levels of chlorine wash, affected product was sent to distribution chain.
Undeclared egg. Challah bread was mislabeled as Columbia Sliced bread and the label does not declare egg.
May contain undeclared cashews (tree nut)
Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil.
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
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.
