FDA recall, , Moderate risk
AVID Medical Halyard Standard Line Insertion Pack
The Halyard STANDARD LINE INSERTION PACK has defective silicone seals that may cause fluid occlusion or leakage.
Summary by Recall Canary from the FDA notice
What happened
AVID Medical, Inc. of Toano, Virginia, recalled its Halyard Standard Line Insertion Pack, a convenience kit. The recall began on May 19, 2026, and was added to the FDA's Enforcement Report on July 22, 2026. The recall affects 112 kits distributed in California.
The agency stated that defects in the silicone seal may result in doming of the seal due to improper sealing, potentially leading to fluid occlusion or leakage.
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?
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 Standard Line Insertion Pack
- Model number
- PVHM234-01
- UDI-DI
- 10809160416761
- Lot code
- 1597314
- 1599022
Recall details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the state of California.
- Company
- AVID Medical, Inc.Toano, Virginia
- Hazard
- Device defect
- 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
- Event ID
- 99250
- Recall number
- Z-2772-2026
- Quantity recalled
- 112 kits
All recalls from AVID Medical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
