- Recalling firm
- GRI Medical & Electronic Technology Co., Ltd.
- Reason for recall
- Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
- Affected products (lot / model / serial)
- 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
- Units affected
- 396 kits
- Distribution pattern
- US Nationwide distribution in the state of MS.
- Firm location
- Jia Xing, N/A, China
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0077-2027
- Recall initiated
- August 26, 2026
- FDA classification date
- October 2, 2026
- FDA report date
- October 14, 2026
- FDA event ID
- 99813
- Last updated on HTM Vibe
- October 21, 2026
