Z-0092-2027 Class II Ongoing
FDA device recall Z-0092-2027 was initiated by AVID Medical, Inc. on Aug 10, 2026 and is designated Class II. Reason for recall: Product may be potentially contaminated with a lubricant used during the manufacturing process. The recall status is ongoing. Affected quantity: 144.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 14, 2026
- Initiation Date
- Aug 10, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 144
Product Description
DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;
Reason for Recall
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
Code Information
1. Model/Item Number (Kit): SAMM064-27; UDI-DI: 10809160439708; Kit Lot Numbers: 1657586, 1658104, 1671251; 2. Model/Item Number (Kit): SAMM064-28; UDI-DI: 10809160516201; Kit Lot Numbers: 1698700; Recalled Supplier Component (in kit): A303416A; Recalled Supplier Lot Number (in kit): NGKU1749, NGKV0359;
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0092-2027
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026