Ansell Healthcare Products LLC
Also registered as Ansell Healthcare Products, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3011209798
- Devices
- 36
- Registrations
- FDA
- FDA recalls
- 273 ongoing
Catalogue
Search and filter all 36 devicesCompany details
- FDA FEI number
- 3011209798
- Address
- 2301 Robb Drive, Reno, NV, 89523
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 1
- 2021 0
- 2022 1
- 2023 2
- 2024 0
- 2025 0
- 2026 0
2023
- 3 Aug 2023 Z-0096-2024 Class II Ongoing Some surgical glove sterile pouches were not completely sealed.
Full distribution text
- 3 Aug 2023 Z-0097-2024 Class II Ongoing Some surgical glove sterile pouches were not completely sealed.
Full distribution text
- 3 Aug 2023 Z-0096-2024 Class II Ongoing Some surgical glove sterile pouches were not completely sealed.
2022
- 19 Feb 2022 Z-0838-2022 Class II Ongoing Transport company failed to stop at the border for required FDA inspection.
2020
- 19 Aug 2020 Z-0051-2021 Class II Terminated Examination gloves were shipped inadvertently, without to verify barrier integrity.
Full distribution text
- 19 Aug 2020 Z-0051-2021 Class II Terminated Examination gloves were shipped inadvertently, without to verify barrier integrity.
2016
- 24 Oct 2016 Z-0893-2017 Class II Terminated Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove.
2013
- 14 Jan 2013 Z-0838-2013 Class II Terminated 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.
Full distribution text
- 14 Jan 2013 Z-0838-2013 Class II Terminated 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.
2012
- 5 Nov 2012 Z-0717-2013 Class II Terminated One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.
2011
- 4 Aug 2011 Z-3114-2011 Unclassified (pre-2012) Terminated Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
- 4 Aug 2011 Z-3115-2011 Unclassified (pre-2012) Terminated Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
- 4 Aug 2011 Z-3116-2011 Unclassified (pre-2012) Terminated Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
Show the 25 most recent of 27 recalls
2011
- 4 Aug 2011 Z-3117-2011 Unclassified (pre-2012) Terminated Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
- 10 Jun 2011 Z-2840-2011 Unclassified (pre-2012) Terminated Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
- 10 Jun 2011 Z-2841-2011 Unclassified (pre-2012) Terminated Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
- 10 Jun 2011 Z-2842-2011 Unclassified (pre-2012) Terminated Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
- 10 Jun 2011 Z-2843-2011 Unclassified (pre-2012) Terminated Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
- 10 Jun 2011 Z-2844-2011 Unclassified (pre-2012) Terminated Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
- 10 Jun 2011 Z-2845-2011 Unclassified (pre-2012) Terminated Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
- 10 Jun 2011 Z-2846-2011 Unclassified (pre-2012) Terminated Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
- 10 Jun 2011 Z-2847-2011 Unclassified (pre-2012) Terminated Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
2010
- 3 Sep 2010 Z-0621-2011 Unclassified (pre-2012) Terminated open package seams on sterile gloves
2009
- 1 May 2009 Z-1583-2009 Unclassified (pre-2012) Terminated Premature degradation which could result in tearing during use.
- 1 May 2009 Z-1584-2009 Unclassified (pre-2012) Terminated Premature degradation which could result in tearing during use.
- 1 May 2009 Z-1585-2009 Unclassified (pre-2012) Terminated Premature degradation which could result in tearing during use.
- 1 May 2009 Z-1586-2009 Unclassified (pre-2012) Terminated Premature degradation which could result in tearing during use.
- 1 May 2009 Z-1587-2009 Unclassified (pre-2012) Terminated Premature degradation which could result in tearing during use.
Frequently asked questions
How many devices does ANSELL HEALTHCARE PRODUCTS LLC have in the registry?
The registry currently lists 36 devices for ANSELL HEALTHCARE PRODUCTS LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list ANSELL HEALTHCARE PRODUCTS LLC's devices?
Among its 36 most recently registered devices, ANSELL HEALTHCARE PRODUCTS LLC has devices listed in FDA 510(k) (36 devices).
What risk classes do ANSELL HEALTHCARE PRODUCTS LLC's devices fall under?
Among its 36 most recently registered devices, the classes recorded for ANSELL HEALTHCARE PRODUCTS LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for ANSELL HEALTHCARE PRODUCTS LLC?
FDA recall records list 27 recalls initiated by ANSELL HEALTHCARE PRODUCTS LLC, the most recent initiated on 3 Aug 2023. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from ANSELL HEALTHCARE PRODUCTS LLC in the registry?
The most recently registered devices listed for ANSELL HEALTHCARE PRODUCTS LLC include Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs, MICRO-TOUCH NITRILE, MICRO-TOUCH NITRAFREE and MICRO-TOUCH NITRA FREE.