Complete FDA and NHTSA recall records dated in 2018, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
General Motors LLC (GM) is recalling certain 2019 Buick Encore, Chevrolet Spark, Traverse, and Trax vehicles. The Sensing Diagnostic Module (SDM) on these vehicle may not have been turned…
Honda (American Honda Motor Co.) is recalling certain 2017-2019 Acura MDX, 2017-2018 Acura MDX Sport Hybrid, 2018-2019 Honda HR-V and Honda Odyssey, and 2016 Honda HR-V vehicles. The rear…
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5¿C while in Automatic mode. 2. Users may experience a Remove from Use code 9…
Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue.
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous…
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose…
Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units
The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a…
The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System Engineers (FSE) can service the associated cells…
The system's IFU contains a list of generators that the have been deemed compatible. Recent reports indicate that one energy platform is not compatible with the system. Therefore, it has…
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose…
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose…
Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline
GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the…
The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in…
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous…
One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous…
The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in…
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.
