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U.S. Department of Health and Human Services

Class 2 Device Recall HALYARD Laparoscopy Comprehensive Pack II

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 Class 2 Device Recall HALYARD Laparoscopy Comprehensive Pack IIsee related information
Date Initiated by FirmAugust 26, 2026
Date PostedOctober 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0077-2027
Recall Event ID 99813
Product Classification laparoscopy kit - Product Code FDE
ProductHALYARD Laparoscopy Comprehensive Pack II REF: 49332
Code Information 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
FEI Number 3004911384
Recalling Firm/
Manufacturer		 GRI Medical & Electronic Technology Co., Ltd.
1805 Honggao Road
Nanhu District
Jia Xing China
For Additional Information ContactMartin Dean Paugh
+1-678-5238977
Manufacturer Reason
for Recall		Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
FDA Determined
Cause 2		Labeling design
ActionOn August 26, 2026, GRI Medical & Electronics Technology Co., Ltd is a Urgent: Medical Device Recall Notification via Email to affected consignees. GRI ask consignees to take the following action: 1. Immediately segregate all affected product lots in a dedicated, clearly marked quarantine zone within your warehouse and all downstream hospital storage areas. Use prominent red labels stating RECALL DO NOT USE OR DISTRIBUTE to separate defective kits from compliant inventory. 2. Cease all outbound shipments, internal transfers and cross-facility redistribution of every lot of 49332 Laparoscopy Comprehensive Pack II. 3. Conduct a full physical inventory count of all recalled units on hand and document exact quantities per lot number for submission to GRI. 4. Share this notice with all staff who need awareness and any facility in which the affected product has been transferred to. 5. Within 3 business days customers are requested to complete and return the Recall Acknowledgment Form via the following official channels: Affairs team at RecallResponses@GRI-usa.com.
Quantity in Commerce396 kits
DistributionUS Nationwide distribution in the state of MS.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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