The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0388-2025·Announced 2024-11-20

Halyard AORTA PACK Surgical Kit Recalled for Loose Metal Flakes

Halyard AORTA PACK surgical kits are recalled because sponge forceps and towel clamps may contain loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall addresses potential contamination of surgical instruments with loose metal flakes that could enter a patient's surgical site. Although this presents a risk of local reactions or foreign body reactions, no illnesses or injuries have been reported. Per the FDA severity rubric, risk-of-harm products without reported injury are classified as High.

Plain-English summary

AVID Medical, Inc. is recalling the Halyard AORTA PACK (Model ESJH004-02), a medical convenience kit for surgical use. The kit is distributed nationwide across the United States, with lot number 1585536.

The recall involves sponge forceps and towel clamps that may contain small loose metal flakes. These flakes could potentially detach from the components and enter a patient's surgical site undetected, potentially causing local reactions or foreign body reactions.

The recalled product

Product
Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02
Manufacturer
AVID Medical, Inc.
Category
Medical Device — Surgical Kit
Hazard
Affected units
36

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • GTIN: 10809160355770 Lot Number: 1585536

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 73 recalled by AVID Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 73 products in this recall →

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