RegWardenFDA facility compliance records
Company

ANSELL HEALTHCARE PRODUCTS LLC

6 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2012: 1 recalls; 2013: 1 recalls; 2016: 1 recalls; 2020: 1 recalls; 2022: 1 recalls; 2023: 1 recalls1’121’13’14’151’16’17’18’191’20’211’221’23’24’25’26
  • Recalls (6)

Registered facilities (10)

Recalls & enforcement

  • Class IIOngoing2023-08-03
    Some surgical glove sterile pouches were not completely sealed.
  • Class IIOngoing2022-02-19
    Transport company failed to stop at the border for required FDA inspection.
  • Class IITerminated2020-08-19
    Examination gloves were shipped inadvertently, without to verify barrier integrity.
  • Class IITerminated2016-10-24
    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.
  • Class IITerminated2013-01-14
    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 conc…
  • Class IITerminated2012-11-05
    One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “ANSELL HEALTHCARE PRODUCTS LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8020065-ansell-healthcare-products-llc/

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