FDA recall, , Moderate risk
Halyard Minor Pack
Halyard Minor Pack may have open seals on header bags, compromising sterility.
Summary by Recall Canary from the FDA notice
What happened
AVID Medical, Inc., of Toano, Virginia, is voluntarily recalling 108 kits of Halyard MINOR PACK because of the potential for open seals on header bags, which can compromise sterility. The recall was initiated by the firm on September 8, 2026, and was added to the FDA's Enforcement Report on November 3, 2026.
The product was distributed through a distributor in the state of Illinois. Customers were notified by e-mail. The recall was classified by the FDA on November 3, 2026.
What to do
This device went to hospitals and other health care facilities, which handle the recall. If you are a patient and have questions about a device used in your care, ask your doctor or the facility.
Is yours affected?
Match the model number, UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Halyard Minor Pack
- Model number
- VASF105-08
- UDI-DI
- 10809160451960
- Lot code
- 1659384
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Nov 2, 2026
- Sold in
U.S Nationwide distributor in the state of Illinois.
- Recalled by
- AVID Medical, Inc.Toano, Virginia
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 99967
- Recall number
- Z-0331-2027
- Quantity recalled
- 108 kits
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
All recalls from AVID Medical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
AVID Medical began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
