HALYARD Laparoscopy Comprehensive Pack II REF: 49332
Summary
The FDA issued a Class II for HALYARD Laparoscopy Comprehensive Pack II REF: 49332 by GRI Medical & Electronic Technology Co., Ltd.. Reason: Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter.
Details
Source
Device Recall
External ID
Z-0077-2027
Action Date
2026-10-14
Status
Ongoing
Category
device
Product Description
HALYARD Laparoscopy Comprehensive Pack II REF: 49332
Lot/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
Quantity Affected: 396 kits
Reason for Recall
Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
Distribution
US Nationwide distribution in the state of MS.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-26
Company
Jia Xing, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 220 device recalls issued in the same week, part of 502 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GRI Medical & Electronic Technology Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GRI Medical & Electronic Technology Co., Ltd. have FDA actions?
This is the only FDA action we have on record for GRI Medical & Electronic Technology Co., Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0077-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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