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Recall

Class II — Ansell Healthcare Products LLC

Recalling firmANSELL HEALTHCARE PRODUCTS LLC
Registered facilityView this company's 10 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonSome surgical glove sterile pouches were not completely sealed.
ProductGAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
Quantity1511
DistributionWorldwide - US Nationwide distribution in the states of IN, OH, NY, VA, IL, TN, GA, NY, SC, WI, FL and the country of CA.
Initiated2023-08-03
Classified2023-10-11
Recall numberZ-0096-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Ansell Healthcare Products LLC (Z-0096-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93045/

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