← FDA ENFORCEMENT
Z-0094-2027Class 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
59
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

ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;

Code / lot info

1. Model/Item Number (Kit): SHND419-08; UDI-DI: 10809160502389; Kit Lot Numbers: 1680504, 1695337; Recalled Supplier Component (in kit): A319514AM; Recalled Supplier Lot Number (in kit): NGKW2687, NGKV2393;

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 →