The Recall Desk
HighFDA (Devices)·Z-0385-2025·Announced 2024-11-20

Medical Surgical Kit Recalled for Potential Loose Metal Flake Hazard

AVID Medical recalls Halyard D & C surgical convenience kits due to potential metal flakes that could detach from forceps and clamps. Affected lot 1596759 was distributed nationwide.

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 recall of surgical instruments with potential for foreign body contamination in surgical sites. No illnesses or injuries have been reported in the source. This represents a risk-of-harm scenario without confirmed injury, classified as High per the rubric.

Plain-English summary

AVID Medical, Inc. is recalling Halyard D & C PACK-CKC medical convenience kits (model BMGT003-02, lot number 1596759) distributed nationwide. The recall affects surgical instruments included in these kits.

The sponge forceps and towel clamps in these kits may develop small loose metal flakes that could detach during use and enter a patient's surgical site. Once in the surgical site, these metal flakes may cause local reactions or foreign body reactions.

Healthcare facilities and providers using this lot should cease use and contact the manufacturer for guidance.

The recalled product

Product
Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02
Manufacturer
AVID Medical, Inc.
Category
Medical Device
Hazard
  • foreign-body
  • metal-flakes

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: 10809160392027 Lot Number: 1596759

Distribution

Distributed nationwide across the United States.

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