AVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
AVID Medical, Inc. is recalling 130 Halyard Total Joint kits because the labeling fails to identify that the statlock component contains natural rubber latex.
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 labeling deficiency regarding a common allergen (latex) without reported illnesses, fitting the criteria for moderate severity.
Plain-English summary
AVID Medical, Inc. is recalling 130 kits of the Halyard TOTAL JOINT (Model/Catalog Number: MSBM036-03) due to a labeling deficiency. The product labeling fails to identify that the statlock component contains natural rubber latex.
The affected units are identified by Lot Number 1673233 and UDI 10809160457887. The products were distributed nationwide in the United States, specifically in the states of Mississippi and Texas.
Consumers and healthcare facilities should stop using the affected kits and contact AVID Medical, Inc. for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 130
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)
- Lot Code: Lot Number: 1673233 UDI: 10809160457887
Distribution
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