Anika Hyalomatrix Wound Dressings Recalled for Packaging Degradation
Anika Therapeutics is recalling Hyalomatrix wound dressings because PVC in the packaging degraded during sterilization, potentially compromising product integrity.
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 the source text describes a potential long-term compromise of product integrity without reporting any specific injuries, illnesses, or immediate hazards, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Anika Therapeutics, Inc. is recalling specific lots of Hyalomatrix wound dressings. The affected products include product numbers 651105, 651103, 651104, and 651301. The recall involves 1,711 units distributed nationwide in the United States, specifically within the state of Illinois.
The recall was initiated because the products are susceptible to degradation resulting from the decomposition of PVC in the packaging material during the sterilization process. This decomposition caused degradation of the film. Over the long term, it is possible that the integrity of the product may be compromised.
Hyalomatrix is a bi-layered, sterile, flexible wound dressing intended for the management of various wounds, including partial and full-thickness wounds, second-degree burns, pressure ulcers, and surgical wounds. The device is intended for one-time use. Consumers and healthcare providers should stop using the affected lots and contact Anika Therapeutics for further instructions.
The recalled product
- Product
- Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl…
- Manufacturer
- Anika Therapeutics, Inc.
- Category
- Medical Device — Wound Care
- Affected units
- 1,711
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 (9)
- 2017017A
- 2017033A
- 2017034A
- 2017031A
- 2017065A
- 2017066A
- 2017007A
- 2017008A
- 2017030A
Distribution
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