The Recall Desk
HighFDA (Devices)·Z-0448-2025·Announced 2024-11-20

Medical Convenience Kits Recalled for Potential Loose Metal Flakes in Surgical Instruments

AVID Medical is recalling Halyard MANIFOLD CATH PACK medical convenience kits because sponge forceps and towel clamps may shed metal flakes 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: This is an FDA Class II medical device recall with potential foreign body and contamination risk in surgical contexts, but without reported illnesses or injuries. Per the rubric, risk-of-harm products without confirmed injury are scored at 3 (High).

Plain-English summary

AVID Medical, Inc. is recalling Halyard MANIFOLD CATH PACK medical convenience kits (Model VMED005-03) due to potential metal flakes that may detach from sponge forceps and towel clamps included in the kits. The affected lot numbers are 1599372 and 1607988. A total of 232 units were distributed nationwide.

Metal flakes from the surgical instruments may enter a patient's surgical site undetected, potentially causing local reactions or foreign body reactions.

Healthcare providers and patients using these kits should discontinue use immediately and contact AVID Medical, Inc. with questions or to report any adverse events related to this recall.

The recalled product

Product
Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03
Manufacturer
AVID Medical, Inc.
Category
Medical Device — Surgical Instruments / Medical Kits
Hazard
  • foreign-body
  • 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 (2)

  • GTIN: 10809160334904 Lot Number: 1599372
  • 1607988

Distribution

Distributed nationwide across the United States.

Related recalls

Same category