AVID Medical, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0387-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02

Product Classification:

Class II

Date Initiated: September 20, 2024

Date Posted: November 20, 2024

Recall Number: Z-0387-2025

Event ID: 95515

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

Status: Ongoing

Product Quantity: 114 eaches

Code Information:

GTIN: 10809160355725 Lot Number: 1597931

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated