Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology… — Class II medical device recall Z-0838-2022
Ongoing recall by Ansell Healthcare Products LLC, reported 2022-04-06, distributed in AZ, CA, NV, TX, UT, WA. Transport company failed to stop at the border for required FDA inspection.
| Recall number | Z-0838-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ansell Healthcare Products LLC, Reno, NV, United States |
| Recall initiated | 2022-02-19 |
| Classified | 2022-03-30 |
| Reported by FDA | 2022-04-06 |
| Distributed | AZ, CA, NV, TX, UT, WA |
| Quantity | 74 cases |
| UPC / GTIN / UDI-DI | 00884792385244 |
| Lot numbers | 2107481604 |
| Model numbers | 20685275 |
Product
Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
Reason for recall
Transport company failed to stop at the border for required FDA inspection.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0838-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.