Device recall
HALYARD Laparoscopy Comprehensive Pack II REF: 49332
- Recall number
- Z-0077-2027
- Event id
- 99813
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- GRI Medical & Electronic Technology Co., Ltd.
- Report date
- Oct 14, 2026
- Posted
- Oct 2, 2026
- Initiated
- Aug 26, 2026
- Center classification date
- Oct 2, 2026
- Product code
- FDE
- Device type
- Laparoscopy Kit
- Reason
- Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
- Root cause
- Labeling design
- Quantity
- 396 kits
- Code info
- 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
- Distribution
- US Nationwide distribution in the state of MS.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Jia Xing, N/A, China