Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may…
Unable to charge the battery pack- battery packs will allow the batteries to be charged if the voltage of any cell is below 2.5V. When this occurs, the battery pack will not accept the…
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler,…
During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).
Class IIFDA: OngoingBecton Dickinson Infusion Therapy Systems Inc.
Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant.…
Class IIFDA: OngoingBecton, Dickinson and Company, BD Biosciences
Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into…
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler,…
Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment…
Class IIFDA: OngoingBelmont Instrument Corporation
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection,…
Class IIFDA: OngoingJohnson & Johnson Surgical Vision, Inc.
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
About the 2022 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.