Class II — Anika Therapeutics, Inc.
| Recalling firm | ANIKA THERAPEUTICS, INC. |
|---|---|
| Registered facility | ANIKA THERAPEUTICS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in the packaging material during sterilization, which resulted in degradation of the film. Over the long term it is possible that product integrity may be compromised. |
| 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 ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFFl 1 wound contact layer biodegradable matrix acts as a scaffold for cellular invasion and capillary growth. Hyalom… |
| Quantity | 1711 |
| Distribution | US Nationwide Distribution in the state of IL. |
| Initiated | 2018-05-10 |
| Classified | 2018-07-11 |
| Terminated | 2019-05-10 |
| Recall number | Z-2423-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Anika Therapeutics, Inc. (Z-2423-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80291/
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