Recall Z-0077-2027— GRI Medical & Electronic Technology Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by GRI Medical & Electronic Technology Co., Ltd., initiated 2026-08-26. FDA's recall record names no specific 510(k) clearance for this event. Product: HALYARD Laparoscopy Comprehensive Pack II REF: 49332. Reason: Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter.
- Recalling firm
- GRI Medical & Electronic Technology Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-26
- Firm location
- Jia Xing, N/A, China
Product description
HALYARD Laparoscopy Comprehensive Pack II REF: 49332
Reason for recall
Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.