Z-0105-2027 Class II Ongoing

Recalled by AVID Medical, Inc. — Toano, VA

FDA device recall Z-0105-2027 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: 28.

Recall Details

Product Type
Devices
Report Date
Oct 14, 2026
Initiation Date
Aug 10, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
28

Product Description

GYN LAPAROSCOPY PACK; Model/Item Number (Kit): NAMC436-12;

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

Model/Item Number (Kit): NAMC436-12; UDI-DI: 10809160468470; Kit Lot Numbers: 1697826; Recalled Supplier Component (in kit): A119216M; Recalled Supplier Lot Number (in kit): NGKT3314;

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0105-2027
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.