The Recall Desk
HighFDA (Devices)·Z-0426-2025·Announced 2024-11-20

Surgical Kit Components Recalled for Potential Metal Fragment Detachment

AVID Medical is recalling Halyard ORAL SURGERY HEAD medical convenience kits (Model SAMM029-15) due to potential loose metal flakes that could detach from forceps and clamps and enter the surgical site, posing risk of 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: FDA Class II medical device recall with risk of foreign body reactions in a surgical setting. No illnesses or injuries have been reported, making this a risk-of-harm product where injury is theoretical but plausible, meeting the rubric criterion for Score 3.

Plain-English summary

AVID Medical, Inc. is recalling Halyard ORAL SURGERY HEAD medical convenience kits (Model Number SAMM029-15, Lot Number 1595714) distributed nationwide in the United States.

The sponge forceps and towel clamps included in these kits are associated with small loose metal flakes that potentially could detach from the components. If metal flakes enter a patient's surgical site undetected, they may cause local reactions or possible foreign body reactions.

This recall affects lot number 1595714, which consists of 29 units distributed nationwide.

The recalled product

Product
Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15
Manufacturer
AVID Medical, Inc.
Category
Medical Device — Surgical Instruments / Kits
Hazard
  • metal-flakes
  • foreign-body-reaction

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: 10809160382172 Lot Number: 1595714

Distribution

Distributed nationwide across the United States.

Related recalls

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