Surgical Kit Components Recalled for Potential Metal Fragment Detachment
AVID Medical is recalling Halyard ORAL SURGERY HEAD medical convenience kits (Model SAMM029-15) due to potential loose metal flakes that could detach from forceps and clamps and enter the surgical site, posing 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: FDA Class II medical device recall with risk of foreign body reactions in a surgical setting. No illnesses or injuries have been reported, making this a risk-of-harm product where injury is theoretical but plausible, meeting the rubric criterion for Score 3.
Plain-English summary
AVID Medical, Inc. is recalling Halyard ORAL SURGERY HEAD medical convenience kits (Model Number SAMM029-15, Lot Number 1595714) distributed nationwide in the United States.
The sponge forceps and towel clamps included in these kits are associated with small loose metal flakes that potentially could detach from the components. If metal flakes enter a patient's surgical site undetected, they may cause local reactions or possible foreign body reactions.
This recall affects lot number 1595714, which consists of 29 units distributed nationwide.
The recalled product
- Product
- Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 29
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: 10809160382172 Lot Number: 1595714
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 →Related recalls
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