← FDA ENFORCEMENT
Z-0097-2027Class II

AVID Medical, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
AVID Medical, Inc.
Product type
Device
Status
Ongoing
Report date
2026-10-14
Distribution
US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
Firm state
VA
Product quantity
124
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Product description

PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;

Code / lot info

1. Model/Item Number (Kit): UFCF004-06; UDI-DI: 10809160487334; Kit Lot Numbers: 1666214, 1672814; 2. Model/Item Number (Kit): UFCF004-07; UDI-DI: 10809160513170; Kit Lot Numbers: 1695181; Recalled Supplier Component (in kit): A119216M; Recalled Supplier Lot Number (in kit): NGKT2404, NGKT3314;

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →