The Recall Desk
HighFDA (Devices)·Z-0384-2025·Announced 2024-11-20

Halyard IR Biopsy Pack recalled for loose metal flakes in surgical kit

AVID Medical is recalling Halyard IR BIOPSY PACK due to loose metal flakes in forceps and towel clamps that could detach and enter the surgical site, potentially causing local or foreign body reactions.

What this means for you

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 a risk of foreign body contamination in a surgical site. No illnesses or injuries have been reported. The hazard is potential rather than confirmed, making this a high-risk situation where injury has not yet been reported, warranting a High (3) severity score.

Plain-English summary

AVID Medical, Inc. is recalling the Halyard IR BIOPSY PACK (Model AVMD019-01), a medical convenience kit used in surgical biopsy procedures. The recall involves lot 1583034 distributed nationwide in the United States.

The recall was initiated because the sponge forceps and towel clamps included in the kit contain components with small loose metal flakes. These flakes could potentially detach from the components during surgical use.

If metal flakes detach, they may enter a patient's surgical site without being detected. This could result in local reactions or foreign body reactions in the patient.

The recalled product

Product
Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01
Manufacturer
AVID Medical, Inc.
Category
Medical Device — Surgical / Biopsy Kit
Hazard
  • metal-flakes
  • foreign-body

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: 10809160304969 Lot Number: 1583034

Distribution

Distributed nationwide across the United States.

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