Data Foundry

Medical device recalls 2023

GAMMEX NON-LATEX PI GREEN Surgical gloves — Class II medical device recall Z-0096-2024

Ongoing recall by Ansell Healthcare Products LLC, reported 2023-10-18, distributed nationwide. Some surgical glove sterile pouches were not completely sealed.

Recall numberZ-0096-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmAnsell Healthcare Products LLC, Reno, NV, United States
Recall initiated2023-08-03
Classified2023-10-11
Reported by FDA2023-10-18
DistributedNationwide (US)
Quantity1,511
Reason classessterility
UPC / GTIN / UDI-DI00884792385206, 00884792385213, 00884792385220, 00884792385237, 00884792385244, 00884792385251, 00884792385268, 00884792385275
Lot numbers2203434204
Model numbers20685255

Product

GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290

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-0096-2024. 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.