Halyard EYE PLASTIC TRAY Medical Kits Recalled for Loose Metal Flakes
AVID Medical recalls Halyard EYE PLASTIC TRAY medical kits due to loose metal flakes in sponge forceps and towel clamps. Metal flakes may contaminate surgical sites, potentially causing foreign body reactions or local tissue damage.
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 an FDA Class II recall with no reported illnesses or hospitalizations. The hazard is theoretical—metal flakes may cause local or foreign body reactions if they enter a surgical site, but no injuries have been reported. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
AVID Medical, Inc. is recalling Halyard EYE PLASTIC TRAY medical convenience kits (Model SAMM054-19, Lot 1591258) due to a manufacturing defect. These kits have been distributed nationwide in the United States.
The recalled kits contain sponge forceps and towel clamps with loose metal flakes that can detach from the surgical components. If these flakes enter a patient's surgical site undetected during use, they may cause local reactions or foreign body reactions.
Affected healthcare facilities and consumers should discontinue use of these products immediately. For information about returning or replacing affected kits, contact AVID Medical, Inc. through the FDA recall details.
The recalled product
- Product
- Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 14
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: 10809160395189 Lot Number: 1591258
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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