HALYARD Laparoscopy Comprehensive Pack II
Laparoscopy packs labeled as latex free contain a latex urethral catheter.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
GRI Medical & Electronic Technology Co., Ltd. recalled 396 HALYARD Laparoscopy Comprehensive Pack II kits, REF: 49332, because the packs, labeled as latex free, were found to contain a latex urethral catheter. The recall began August 26, 2026, and was added to the FDA's Enforcement Report on October 2, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
HALYARD Laparoscopy Comprehensive Pack II REF: 49332
- UDI-DI
- 10680651493320
- 30680651493324
- Lot
- GL25271CXA
- GL25296CXA
- GL26076CXA
Details
- Company began the recall
- Event ID
- 99813
- Company
- GRI Medical & Electronic Technology Co., Ltd.
- Hazard
- Labeling error
- Quantity recalled
- 396 kits
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
