Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 18, 2018
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 cont
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 fi…
Anika Therapeutics, Inc. recalled Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatr… - a moderate-severity action.
Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatr… was recalled by Anika Therapeutics, Inc. in July 18, 2018. Reason: Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in the packaging …. Check the official notice for the remedy. Verify recall #Z-2423-2018 with the FDA Devices before acting.
The recall
Anika Therapeutics, Inc. issued this moderate-severity FDA Devices recall-Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in the packaging ….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- July 18, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2423-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2423-2018) was formally reported on July 18, 2018, with the manufacturer initiating the action on May 10, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Anika Therapeutics, Inc. is listed as the recalling firm, operating out of Bedford, MA. Federal records list the affected scope as 1711.
The documented reason for this recall is: 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 th… Distribution data in the federal record shows the product reached: US Nationwide Distribution in the state of IL.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1711
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2423-2018 |
| Date reported | July 18, 2018 |
| Date initiated | May 10, 2018 |
| Recalling firm | Anika Therapeutics, Inc. |
| Firm location | Bedford, MA |
| Affected scope | 1711 |
| Distribution | US Nationwide Distribution in the state of IL. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2423-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Anika Therapeutics, Inc.. Units affected: 1711.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 18, 2018. Severity: Moderate. Recall number: Z-2423-2018.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the state of IL..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2423-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 18, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.