Ansell Healthcare Products LLC FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 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
NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290Class IIAug 3, 2023Some surgical glove sterile pouches were not completely seal	Some surgical glove sterile pouches were not completely sealed.	Class IIDevices	Aug 3, 2023
GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290Class IIAug 3, 2023Some surgical glove sterile pouches were not completely seal	Some surgical glove sterile pouches were not completely sealed.	Class IIDevices	Aug 3, 2023
Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2Class IIFeb 19, 2022Transport company failed to stop at the border for required	Transport company failed to stop at the border for required FDA inspection.	Class IIDevices	Feb 19, 2022