Halyard EYE PACK Convenience Kits Recalled Due to Incorrect Betadine Concentration
AVID Medical, Inc. is recalling certain Halyard EYE PACK convenience kits because the Betadine solution contained within them has an incorrect concentration.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a concentration error in a medical solution, which falls under low-risk contamination or minor labeling/composition issues without reported injuries.
Plain-English summary
AVID Medical, Inc. is recalling Halyard EYE PACK convenience kits (Model/Catalog Number: LVEY27) due to an incorrect concentration of Betadine solution within the kits.
The affected products include 260 kits with the following lot numbers and expiration dates: Lot 1680076 (expires 12/31/2026) and Lot 1680590 (expires 6/30/2027). These kits were distributed nationwide within the state of California.
Users should check their inventory for the specified model and lot numbers and follow appropriate protocols for recalled medical supplies.
The recalled product
- Product
- Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 260
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)
- 1680590 (6/30/2027).
Distribution
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