CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report
Halyard Laparoscopy Comprehensive Pack II recalled
GRI Medical & Electronic Technology is recalling Halyard Laparoscopy Comprehensive Pack II, distributed nationwide in the US. The recall was initiated on 26 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0077-2027
- FDA event ID
- 99813
- Recalling firm
- GRI Medical & Electronic Technology, Jia Xing, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Aug 2026
- FDA classified
- 2 Oct 2026
- Reported
- 14 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 26 Aug 2026 | Recall initiated by company | |
| 2 Oct 2026 | Classified by FDA | +37 days |
| 14 Oct 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
Product as listed by the FDA
HALYARD Laparoscopy Comprehensive Pack II REF: 49332
Where it was distributed
US Nationwide distribution in the state of MS.
Questions about this recall
Why was it recalled?
Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
Which lots are affected?
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
Where was it sold?
US Nationwide distribution in the state of MS.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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