Ansell Healthcare Products Llc
2301 Robb Drive, Reno, NV, US
Registered product codes
16 product codes
Recent MDR events
40 on file
- NOVAPLUSMay 27, 2026Malfunction25299569
- NOVAPLUSJan 13, 2025Malfunction21136983
- ENCORE RADIATION ATTENUATION GLOVESJun 5, 2024Malfunction19466401
- NOVAPLUSMay 30, 2024Malfunction19422996
- NOVAPLUSNov 3, 2023Malfunction18064760
- GAMMEXMar 15, 2023Malfunction16544939
- POLYMER PATIENT EXAMINATION GLOVEJul 22, 2021Malfunction12210524
- ENCOREJul 8, 2021Malfunction12134062
- GAMMEXJun 21, 2021Malfunction12031478
- MEDICHOICE POLYISOPRENE SURGICAL GLOVES (DISTRIBUTED BY OWENS AND MINOR)May 7, 2021Malfunction11789641
Recalls
27 on file
- Open, ClassifiedOct 11, 2023
Some surgical glove sterile pouches were not completely sealed.
View FDA record ↗ - Open, ClassifiedOct 11, 2023
Some surgical glove sterile pouches were not completely sealed.
View FDA record ↗ - TerminatedFeb 20, 2013
Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking to have all products returned.
View FDA record ↗ - TerminatedJan 24, 2013
One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.
View FDA record ↗ - TerminatedAug 31, 2011
Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
View FDA record ↗ - TerminatedAug 31, 2011
Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
View FDA record ↗ - TerminatedAug 31, 2011
Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
View FDA record ↗ - TerminatedAug 31, 2011
Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
View FDA record ↗ - TerminatedJul 18, 2011
Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
View FDA record ↗ - TerminatedJul 18, 2011
Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
View FDA record ↗
Compliance history
Matched by FEI 3011209798.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.