ENT surgical kit recalled for potentially detachable metal flakes in forceps
AVID Medical is recalling Halyard ENT T and A Pack surgical kits nationwide due to loose metal flakes in sponge forceps and towel clamps that may contaminate surgical sites.
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: FDA Class II recall involving risk-of-harm to surgical patients through potential foreign body contamination. No reported illnesses or injuries have occurred. Per the severity rubric, this qualifies as High (3) as a risk-of-harm product with no injury yet reported.
Plain-English summary
The Halyard ENT T and A Pack (Model EAMC106-02), manufactured by AVID Medical, Inc., is a surgical convenience kit containing instruments for ear, nose, and throat (ENT) procedures. The product was distributed nationwide throughout the United States.
The sponge forceps and towel clamps included in these kits may contain small loose metal flakes that could potentially detach from the components during use.
If metal flakes detach and enter a patient's surgical site undetected, they could cause local reactions or possible foreign body reactions.
The recall affects units with lot numbers 1591242, 1600320, and 1604627. Healthcare providers should verify their lot numbers and take appropriate action if they have affected units.
The recalled product
- Product
- Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 100
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 (3)
- GTIN: 10809160308288 Lot Number: 1591242
- 1600320
- 1604627
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.
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