Z-0417-2025 Class II Ongoing

Recalled by AVID Medical, Inc. — Toano, VA

FDA device recall Z-0417-2025 was initiated by AVID Medical, Inc. on Sep 20, 2024 and is designated Class II. Reason for recall: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing… The recall status is ongoing.

Recall Details

Product Type
Devices
Report Date
Nov 20, 2024
Initiation Date
Sep 20, 2024
Voluntary/Mandated
Voluntary: Firm initiated

Product Description

Halyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03

Reason for Recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Distribution Pattern

US Nationwide distribution.

Code Information

GTIN: 10809160411995 Lot Number: 1598132

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0417-2025
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

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