FDA Enforcement Class II Ongoing

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.

Recall: Z-2512-2025 · Reported September 10, 2025

Enforcement

Recall Number
Z-2512-2025
Event ID
97404
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Integra LifeSciences Corp. (NeuroSciences)
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
September 10, 2025
Initiation Date
August 5, 2025
Classification Date
September 3, 2025
Address
1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States

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

Packaging failures were identified which could lead to a breach in the sterile barrier.

Code Info

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

Distribution

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.

Quantity

111492 units