The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0437-2025·Announced 2024-11-20

Surgical Sponge Forceps and Towel Clamps Recalled for Loose Metal Flakes

AVID Medical is recalling Halyard CATH LAB PACK surgical kits because sponge forceps and towel clamp components may shed loose metal flakes that could enter a patient's surgical site, posing a risk of 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 a risk-of-harm product (surgical device with foreign body contamination potential) where no injuries or illnesses have been reported. The hazard is theoretical—metal flakes may potentially detach and cause harm if they enter a surgical site, but no actual incidents have occurred. Per the severity rubric, this corresponds to High (3).

Plain-English summary

AVID Medical, Inc. is recalling Halyard CATH LAB PACK medical convenience kits (Model Number VANW016-05, Lot Number 1603736). The sponge forceps and towel clamp components in these kits are associated with small loose metal flakes that have the potential to detach during use.

Metal flakes on these components may enter a patient's surgical site undetected. If this occurs, the flakes could cause local reactions or foreign body reactions, posing a risk to patient safety.

The recalled kits have been distributed nationwide throughout the United States. This is a Class II recall issued by the U.S. Food and Drug Administration.

The recalled product

Product
Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05
Manufacturer
AVID Medical, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
42

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: 10809160332719 Lot Number: 1603736

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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