The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0435-2025·Announced 2024-11-20

Halyard C Section Pack surgical kits recalled for loose metal flakes

AVID Medical is recalling Halyard C Section Pack surgical kits due to loose metal flakes on sponge forceps and towel clamps. These flakes may enter a surgical site and cause local reactions or foreign body complications.

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 Class II medical device recall involving loose metal particles in surgical instruments that could contaminate a surgical site and cause foreign body reactions. No illnesses or injuries have been reported. The recall meets the High severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

AVID Medical, Inc. is recalling the Halyard C SECTION PACK medical convenience kits (Model Number SJCS66-02, Lot Number 1610500) due to a potential safety hazard affecting the sponge forceps and towel clamps included in these surgical kits.

The sponge forceps and towel clamps in affected kits may have small loose metal flakes that could detach from the components. If these metal flakes enter a patient's surgical site undetected, they could cause local reactions or foreign body reactions, potentially requiring additional medical intervention.

This recall affects Halyard C Section Pack kits distributed nationwide in the United States.

Healthcare facilities and surgical centers using these kits should stop use of affected lots and contact AVID Medical, Inc. for return or replacement instructions.

The recalled product

Product
Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02
Manufacturer
AVID Medical, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
20

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: 10809160420072 Lot Number: 1610500

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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