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.
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Volvo Cars USA LLC (Volvo) is recalling certain 2019 Volvo XC40 vehicles. The rear seats may not have rear seat back lock strikers, allowing the seat back to move forward during certain…
Chrysler (FCA US LLC) is recalling certain 2018 Jeep Renegade, Compass and Grand Cherokee, RAM 1500 and Promaster, Fiat 500x, Dodge Journey, Challenger, Charger and Durango and Chrysler…
Chrysler (FCA US LLC) is recalling certain 2018-2019 Dodge Grand Caravan and Jeep Compass, 2018 Dodge Journey, and 2019 Jeep Cherokee vehicles. The rear brake caliper pistons on these…
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can…
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can…
The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out…
There were instances where the power cord socket detached from the back of the AMIA cycler when the power cord was unplugged from the socket.
Product contains dry natural rubber latex. Label states Latex Free.
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to the locking screw.
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
Devices may have a loose control bar, which could compromise the ability to control the thickness of the graft. Devices could also have a loose width plate that if undetected, could result…
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.
Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots.
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Underfilled reagent well that could lead to incorrect results
ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part number: 55117), for Envoy 500 systems are observing trouble while calibrating…
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.
