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Open, Classified

HALYARD Laparoscopy Comprehensive Pack II REF: 49332

FDA Recall Z-0077-2027 · Posted 2026-10-02

Recalling FirmGRI Medical & Electronic Technology Co., Ltd.
Recall StatusOpen, Classified
Product CodeFDE
Date Initiated2026-08-26
Product Quantity396 kits

Reason for Recall

Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter

Firm Action

On August 26, 2026, GRI Medical & Electronics Technology Co., Ltd is a Urgent: Medical Device Recall Notification via Email to affected consignees. GRI ask consignees to take the following action: 1. Immediately segregate all affected product lots in a dedicated, clearly marked quarantine zone within your warehouse and all downstream hospital storage areas. Use prominent red labels stating RECALL DO NOT USE OR DISTRIBUTE to separate defective kits from compliant inventory. 2. Cease all outbound shipments, internal transfers and cross-facility redistribution of every lot of 49332 Laparoscopy Comprehensive Pack II. 3. Conduct a full physical inventory count of all recalled units on hand and document exact quantities per lot number for submission to GRI. 4. Share this notice with all staff who need awareness and any facility in which the affected product has been transferred to. 5. Within 3 business days customers are requested to complete and return the Recall Acknowledgment Form via the following official channels: Affairs team at [email protected].

Root Cause

Labeling design

Distribution Pattern

US Nationwide distribution in the state of MS.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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