The Recall Desk

Manufacturer

Ansell Healthcare Products LLC

7 recalls in our database name Ansell Healthcare Products LLC as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2023-10-18

Of the 7 recalls from Ansell Healthcare Products LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–7 of 7

  • HighFDA (Devices)·Z-0096-2024·2023-10-18

    GAMMEX NON-LATEX PI GREEN Surgical Gloves with Unsealed Sterile Pouches

    Ansell is recalling GAMMEX NON-LATEX PI GREEN surgical gloves because some sterile pouches were not completely sealed. Approximately 1,511 units were distributed nationwide across multiple states.

    Product
    GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2024·2023-10-18

    Surgical gloves recalled for incomplete sterile pouch sealing

    Ansell Healthcare Products LLC has recalled certain NOVAPLUS GAMMEX NON-LATEX PI GREEN surgical gloves because some sterile pouches were not completely sealed. Improper sealing could allow contamination before use.

    Product
    NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0838-2022·2022-04-06

    Surgical Gloves Recalled Due to Missed FDA Border Inspection

    Ansell is recalling Gammex Non-Latex PI Green surgical gloves (size 7 1/2) because the product was not submitted for required FDA inspection at the border. Distribution included Arizona, California, Nevada, Texas, Utah, and Washington.

    Product
    Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0051-2021·2020-10-14

    Ansell Microflex Diamond Grip Examination Gloves Recalled for Barrier Integrity Verification

    Ansell Healthcare Products LLC is recalling Microflex Diamond Grip Examination Gloves because they were shipped without verification of barrier integrity.

    Product
    MICROFLEX 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2017·2016-12-28

    Ansell Recalls Gammex Surgical Gloves Due to Latex Contamination

    Ansell Healthcare Products is recalling 15 cases of Gammex Non-Latex Surgical Gloves because they incorrectly contained natural rubber latex gloves.

    Product
    Gammex 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.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0838-2013·2013-02-27

    Ansell Recalls LifeStyles ZERO 10 Latex Condoms Due to Breakage Complaints

    Ansell Healthcare Products LLC is voluntarily recalling LifeStyles ZERO 10 latex condoms due to complaints about difficulty unrolling and breakage.

    Product
    LifeStyles 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 transmi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0717-2013·2013-01-30

    Ansell Recalls Lifestyles Condoms Due to Mislabeling of Ultra Thin Style

    Ansell Healthcare Products LLC is recalling one lot of Lifestyles Pleasure Collection condoms because Ultra Thin condoms were included instead of the labeled Skyn style.

    Product
    Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin. UPC 0-70907-02625-0.
    Category
    Medical Device
    Distribution
    Distributed nationwide