The Recall Desk
HighFDA (Devices)·Z-0389-2025·Announced 2024-11-20

Surgical Instruments Recalled for Loose Metal Flakes in Set-Up Packs

AVID Medical is recalling Halyard GENERAL SET UP PACK medical convenience kits nationwide due to sponge forceps and towel clamps that may shed small metal flakes into patients' surgical sites, risking local reactions and 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: This is a Class II FDA recall of surgical instruments with a potential serious health risk—metal flakes may enter a patient's surgical site causing local or foreign body reactions. No illnesses or injuries have been reported to date, but the risk-of-harm nature of the product and potential for serious surgical site complications justifies a High severity rating.

Plain-English summary

AVID Medical, Inc. is recalling the Halyard GENERAL SET UP PACK (Model Number ESJH005-02), a medical convenience kit containing sponge forceps and towel clamps. The recall affects 1,434 units distributed nationwide in the United States. The affected lot number is 1583946.

The sponge forceps and towel clamps in these kits may shed small loose metal flakes. These flakes could potentially detach from the instruments and enter a patient's surgical site undetected, causing local tissue reactions or foreign body reactions.

Healthcare facilities and medical professionals who use or have used these kits should identify and quarantine any remaining inventory. Any patients who may have been exposed to these instruments during surgical procedures should consult with their healthcare provider if they experience unexpected reactions or complications at the surgical site. Contact AVID Medical, Inc. for instructions on returning or replacing affected units.

The recalled product

Product
Halyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02
Manufacturer
AVID Medical, Inc.
Category
Medical Device — Surgical instruments
Hazard
  • metal-flakes
  • foreign-body-risk
  • surgical-site-hazard

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: 10809160400111 Lot Number: 1583946

Distribution

Distributed nationwide across the United States.

Related recalls

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