Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Pr...
FDA Device Recall #Z-2512-2025 — Class II — August 5, 2025
Recall Summary
| Recall Number | Z-2512-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 5, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Integra LifeSciences Corp. (NeuroSciences) |
| Location | Princeton, NJ |
| Product Type | Devices |
| Quantity | 111492 units |
Product Description
Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey Manuka (Leptospermum) honey is a medical-grade honey that is harvested from bees in New Zealand. Researchers have found that this species has unique components that make it ideal for wounds.
Reason for Recall
Packaging failures were identified which could lead to a breach in the sterile barrier.
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.
Lot / Code Information
Model/Catalog Numbers: (1) CVS9370613, (2) CVS937404 UDIs: (1) 00050428510377*, (2) 0050428462584* (* UDI owned by CVS) Lot#s: (1) 024622, (2) 014622, 044622, 020923, 040923, 054623, 020124, 014524; CVS937404 UDI - 0050428462584* Lot #s 014622 044622 020923 040923 054623 020124 014524 * UDI owned by CVS
Other Recalls from Integra LifeSciences Corp. (NeuroScie...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2173-2026 | Class II | Codman CerebroFlo EVD Catheter with Endexo Tech... | Apr 10, 2026 |
| Z-1819-2026 | Class II | Cytal Burn Matrix 7x10 cm. Product ID: BMM0710. | Mar 19, 2026 |
| Z-1818-2026 | Class II | Cytal Wound Matrix 2-Layer 10x15 cm. Product ID... | Mar 19, 2026 |
| Z-1816-2026 | Class II | Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: ... | Mar 19, 2026 |
| Z-1817-2026 | Class II | Cytal Wound Matrix 2-Layer 7x10 cm. Product ID:... | Mar 19, 2026 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.