Recall Register

Food, drugs, devices › Firms

Ansell Healthcare Products LLC

FDA recalling firm · 6 enforcement events · 7 product records · 2012–2023 · NV, NJ

Ansell Healthcare Products LLC has 6 FDA enforcement events on this register (7 product records) between 2012 and 2023: 6 device; the busiest year was 2012 with 1.

0% of its events are Class I; the most common class is Class II (6). 2 events are listed as ongoing; the recalling firm's address is in NV and NJ.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
3 Aug 2023GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290DeviceClass II2Ongoing
19 Feb 2022Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2DeviceClass II1Ongoing
19 Aug 2020MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner s hand or finger to prevent contamination between patient and examiner.DeviceClass II1Terminated
24 Oct 2016Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products LLC. 1635 Industrial Road Dothan, AL 36303, USA TEL…DeviceClass II1Terminated
14 Jan 2013LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).DeviceClass II1Terminated
5 Nov 2012Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin. UPC 0-70907-02625-0.DeviceClass II1Terminated

By type and class

Device6
Class II6

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

12
14
16
18
20
22
24
26
Enforcement events for Ansell Healthcare Products LLC by year initiated.

Questions and answers

How many FDA recalls has Ansell Healthcare Products LLC had?

6 enforcement events (7 product records) on this register, 2012–2023: 6 device.

Are any Ansell Healthcare Products LLC recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are Ansell Healthcare Products LLC recalls?

6 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.