Class II — Ansell Healthcare Products LLC
| Recalling firm | ANSELL HEALTHCARE PRODUCTS LLC |
|---|---|
| Registered facility | View this company's 10 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Transport company failed to stop at the border for required FDA inspection. |
| Product | Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2 |
| Quantity | 74 cases |
| Distribution | U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None |
| Initiated | 2022-02-19 |
| Classified | 2022-03-30 |
| Recall number | Z-0838-2022 |
| Initiation | Voluntary: 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-0838-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89691/
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