Class II recall Z-0077-2027: GRI Medical & Electronic Technology Co., Ltd.
Class II recall Z-0077-2027: GRI Medical & Electronic Technology Co., Ltd.: GRI Medical & Electronic Technology Co., Ltd. Dated 21 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 1 related FDAPulse records and the 5-column CSV export.
| 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 |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-14
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Class II recall Z-0077-2027: GRI Medical & Electronic Technology Co., Ltd. and 2 N/A peers
- N/A FDAPulse records like this one: 2
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every N/A peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 21 days ago.
What is the FDAPulse record for Class II recall Z-0077-2027: GRI Medical & Electronic Technology Co., Ltd.?
Class II device recall Z-0077-2027 by GRI Medical & Electronic Technology Co., Ltd.: Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
How does Class II recall Z-0077-2027: GRI Medical & Electronic Technology Co., Ltd. compare to other FDAPulse records?
It is 21 days old, still within a typical 45-day follow-up window.
Class II recall Z-0077-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0077-2027 | N/A | 2026-10-14 |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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