# Class II recall Z-0077-2027: GRI Medical & Electronic Technology Co., Ltd.

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

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0077-2027 |
| Recalling firm | GRI Medical & Electronic Technology Co., Ltd. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | HALYARD Laparoscopy Comprehensive Pack II  REF: 49332 |
| Reason | Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter |
| Quantity | 396 kits |
| Distribution | US Nationwide distribution in the state of MS. |
| Recall initiated | 2026-08-26 |
| Reported | 2026-10-14 |
| Firm location | Jia Xing, N/A, China |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 22 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-0077-2027%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.