Summary
The FDA issued a Class II for HEART PREP TRAY; Model/Item Number (Kit): MECV97W; by AVID Medical, Inc.. Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process..
Details
Source
Device Recall
External ID
Z-0102-2027
Action Date
2026-10-14
Status
Ongoing
Category
device
Product Description
HEART PREP TRAY; Model/Item Number (Kit): MECV97W;
Lot/Code Info: Model/Item Number (Kit): MECV97W; UDI-DI: 10809160493113; Kit Lot Numbers: 1691836, 1696316; Recalled Supplier Component (in kit): A319514AM; Recalled Supplier Lot Number (in kit): NGKV2393;
Quantity Affected: 96
Reason for Recall
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Distribution
US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-10
Company
Toano, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 220 device recalls issued in the same week, part of 502 device-related FDA actions this month.
AVID Medical, Inc. has 165 FDA actions in our database, including 165 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AVID Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AVID Medical, Inc. have FDA actions?
AVID Medical, Inc. has 165 FDA actions in our database, including 165 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0102-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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