AVID Medical Halyard LAVH PACK Recall: Kit Component May Leak After Sterilization
AVID Medical recalls Halyard LAVH PACK Model USAR053-11 with Clearify Visualization System (5303907) due to potential leakage after EO sterilization. Affected units have specific UDI/DI and lot numbers.
Lower-risk recall
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
What happened, in plain English
AVID Medical is recalling Halyard LAVH PACK Model USAR053-11 with Clearify Visualization System (5303907) because a kit component may leak after EO sterilization. This could cause issues with the medical device's function or safety. Read more at govinfonow.com/recall/697901-avid-medical-halyard-lavh-pack-recall-kit-component-may-leak.
Source Summary by GovInfoNow · govinfonow.com/recall/697901-avid-medical-halyard-lavh-pack-recall-kit-component-may-leak · Updated September 14, 2026 · FDA enforcement record: FDA #Z-2964-2026
Cite this page
“AVID Medical Halyard LAVH PACK Recall: Kit Component May Leak After Sterilization.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697901-avid-medical-halyard-lavh-pack-recall-kit-component-may-leak. Based on FDA recall #Z-2964-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2964-2026%22&limit=1).
Why it’s dangerous
The kit component was sterilized using EO (ethylene oxide) instead of the manufacturer's recommended method, which may cause it to leak. This leakage could disrupt the device's operation or safety features.
Who’s affected
Healthcare professionals using the Halyard LAVH PACK for medical procedures are likely affected. Patients using this device may be at risk if the kit component leaks.
How to tell if you have this one
Check for the model number USAR053-11 and catalog number 5303907 on the Halyard LAVH PACK. Affected units have UDI/DI 10809160372357 and lot number 1669869.
- Brand
AVID Medical- Category
Medical device
What to do — step by step
Check Product Details
Identify the model number USAR053-11 and catalog number 5303907 on the Halyard LAVH PACK.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 47 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury?
The recall states the component may leak, but no specific risk of serious injury is mentioned. The danger level is low risk.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2964-2026 (July 10, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2964-2026 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.