← FDA ENFORCEMENT
Z-0077-2027Class II

GRI Medical & Electronic Technology Co., Ltd.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
GRI Medical & Electronic Technology Co., Ltd.
Product type
Device
Status
Ongoing
Report date
2026-10-14
Distribution
US Nationwide distribution in the state of MS.
Firm state
N/A
Product quantity
396 kits
Initiated by
Voluntary: Firm initiated
Reason for recall

Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter

Product description

HALYARD Laparoscopy Comprehensive Pack II REF: 49332

Code / lot 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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →