NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves — Class II medical device recall Z-0097-2024
Ongoing recall by Ansell Healthcare Products LLC, reported 2023-10-18, distributed nationwide. Some surgical glove sterile pouches were not completely sealed.
| Recall number | Z-0097-2024 |
|---|---|
| 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 | 2023-08-03 |
| Classified | 2023-10-11 |
| Reported by FDA | 2023-10-18 |
| Distributed | Nationwide (US) |
| Quantity | 378 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10014566400553, 10014566400607, 10014566400652, 10014566400706, 10014566400751, 10014566400805, 10014566400850, 10014566400904 |
| Lot numbers | 2203434604 |
| Model numbers | V20685255 |
Product
NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
Reason for recall
Some surgical glove sterile pouches were not completely sealed.
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-0097-2024. 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.