Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Hyalomatrix Recalled by Anika Therapeutics, Inc. Due to Hyalomatrix products are susceptible to degradation as a...

Date: May 10, 2018
Company: Anika Therapeutics, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Anika Therapeutics, Inc. directly.

Affected Products

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. Hyalomatrix is indicated for the management of wounds including: partial and full-thickness wounds; second-degree bums; pressure ulcers; venous ulcers; diabetic ulcers; chronic vascular ulcers; tunneled/undetermined wounds; surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence); trauma wounds (abrasions, lacerations, skin tears); and draining wounds. The device is intended for one-time use.

Quantity: 1711

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report