Recall Z-0077-2027 ยท FDE Laparoscopy Kit
GRI Medical & Electronic Technology Co., Ltd.
HALYARD Laparoscopy Comprehensive Pack II REF: 49332
| Date | Oct 2, 2026 (initiated Aug 26, 2026) |
| Status | Open, Classified |
| Reason | Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter |
| Root cause | Labeling design |
| 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 Laparosco |
| Quantity | 396 kits |
| Distribution | US Nationwide distribution in the state of MS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.