The Recall Desk
HighFDA (Devices)·Z-0407-2025·Announced 2024-11-20

Surgical instrument bundle recalled for potentially detachable metal flakes

AVID Medical is recalling Halyard VAG hysterectomy instrument bundles due to loose metal flakes on surgical instruments that could contaminate surgical sites.

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 a clear risk of patient harm from foreign body contamination during surgery. No reported illnesses or injuries are documented in the source, placing this at the High severity level per the rubric.

Plain-English summary

AVID Medical, Inc. is recalling the Halyard VAG HYSTERECTOMY BUNDLE PK (Model LANC022-29, Lot 1594075) due to a quality defect affecting the included surgical instruments.

The bundle contains sponge forceps and towel clamps that may have small, loose metal flakes on their surfaces. These flakes could potentially detach during surgical use and enter a patient's surgical site undetected.

If metal flakes enter the surgical site, they may cause local reactions or possible foreign body reactions in the patient. The recall affects units distributed nationwide in the United States.

Healthcare facilities that have received this product should stop using affected units immediately. Contact AVID Medical for instructions on returning or replacing the recalled product.

The recalled product

Product
Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29
Manufacturer
AVID Medical, Inc.
Category
Medical Device — Surgical Instruments
Hazard
  • foreign-body
  • metal-contamination

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: 10809160368329 Lot Number: 1594075

Distribution

Distributed nationwide across the United States.

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