Complete FDA and NHTSA recall records dated in June 2021.
These records include useful source details for the selected month.
Specific lots may have been manufactured with insufficient or incomplete welds.
Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display interface dismounting from…
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Specific lots may have been manufactured with insufficient or incomplete welds.
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line…
Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to increased…
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor…
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
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.
