Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to
FDA device recall Z-1365-2026 · posted 2026-02-13 · Open, Classified
Recall details
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Reason for recall
- Potential packaging failures, which could lead to a breach in the sterile barrier.
- Action taken
- Integra began notifying consignees on about 01/16/2026 via URGENT: VOLUNTARY MEDICAL DEVICE RECALL letter sent through FedEx and email. Consignees were instructed to immediately cease use of affected units and arrange for their return. Users were instructed to follow-up with their medical provider if the product has been used and they experienced any signs of wound infection. Consignees and distributors were instructed to forward the notification to those who utilize the product for awareness, and to customers, if further distributed. Additionally, consignees and distributors were requested to complete and return the provided Acknowledgement Form.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FRO
- Quantity affected
- 2,906 units
- Distribution
- Worldwide - US Nationwide distribution in the states of TX, MI, FL, IN, MO, CA, VA, NJ, PA, SC, TN, RI, NY and the countries of Australia, Austria, Bahrain, Canada, Finland, France, Germany, Greece, G
- Date initiated
- 2026-01-16
- Date posted
- 2026-02-13
- Location
- Princeton, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Medihoney Wound Gel (K150985) | Derma Sciences, Inc. | 2015-11-19 |