AMO Manufacturing USA, LLC FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and CatClass IIOct 21, 2021Aberrometer and precision laser systems are affected by a re	Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when th	Class IIDevices	Oct 21, 2021
iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesignClass IIOct 21, 2021Aberrometer and precision laser systems are affected by a re	Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when th	Class IIDevices	Oct 21, 2021