The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0392-2025·Announced 2024-11-20

Halyard cardiac surgical kit recalled for loose metal flakes risk

AVID Medical is recalling Halyard cardiac surgical kits (Model ESJH017-03) due to sponge forceps and towel clamps that may shed small metal flakes during surgery. These metal flakes could enter the patient's surgical site, potentially 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: This is an FDA Class II recall involving surgical instruments with loose metal flakes that could enter a patient's surgical site. The source describes potential reactions but does not report actual illnesses or injuries. Per the rubric, a risk-of-harm product where injury has not been reported scores 3 (High).

Plain-English summary

AVID Medical, Inc. is recalling Halyard KIT, CARDIAC ROBOTIC (Model ESJH017-03), a surgical instrument kit containing sponge forceps and towel clamps. The affected product consists of 46 units distributed nationwide in the United States.

Small loose metal flakes are associated with the sponge forceps and towel clamps. These flakes could potentially detach from the components and enter a patient's surgical site undetected, causing local reactions or possible foreign body reactions.

The FDA has classified this as a Class II recall. Healthcare providers and facilities should be aware of this potential risk with the affected lot number 1600678.

The recalled product

Product
Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03
Manufacturer
AVID Medical, Inc.
Category
Medical Device — Cardiac surgical instruments
Hazard
Affected units
46

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: 10809160406144 Lot Number: 1600678

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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