RegWardenFDA facility compliance records
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
StatusTerminated
ReasonExamination gloves were shipped inadvertently, without to verify barrier integrity.
ProductMICROFLEX 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.
Quantity1312 Cases
DistributionU.S. Nationwide distribution including in the states of IL, OK, WI, PA, TX, OH, MI, IN, VA, AR, KS, MO, NV, OR, FL, QC, NJ, NE, KY, AL, TN, LA, NY, SC, MS, MD, CA, GA, SD.
Initiated2020-08-19
Classified2020-10-02
Terminated2021-11-03
Recall numberZ-0051-2021
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-0051-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86352/

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