# Class II recall Z-3289-2026: American Nitrile Operations Llc

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3289-2026 |
| Recalling firm | American Nitrile Operations Llc |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Brand Name: Performance Pro  Product Name: Performance Pro  Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604  Product Description: Blue Nitrile Patient examination gloves |
| Reason | Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to chemical agents leading to irritation or systemic toxicities. |
| Quantity | 99,724,000 |
| Distribution | US Nationwide distribution. |
| Recall initiated | 2026-08-14 |
| Reported | 2026-10-07 |
| Firm location | Grove City, OH, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 29 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3289-2026%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.