HALYARD Laparoscopy Comprehensive Pack II REF: 49332
Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
| Recalling firm | GRI Medical & Electronic Technology Co., Ltd. |
|---|---|
| Reason | Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Oct 14, 2026 |
| Initiated | Aug 26, 2026 |
| Region | N/A, China |
| Distribution | US Nationwide distribution in the state of MS. |
| Quantity | 396 kits |
| Code/Lot | UDI-DI: 10680651493320 (unit level), 30680651493324 (case level) Lot Numbers: GL25271CXA-Expiry Date: 2029/3/30; GL25296CXA-Expiry Date: 2029/3/30; GL26076CXA-Expiry Date: 2029/5/31 |
| Type | Voluntary: Firm initiated |
| Recall number | Z-0077-2027 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: Z-0077-2027)
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