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Recall Observatory FDA recall evidence

Device product

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.

Z-2512-2025

August 05, 2025

Class II

Product summary

Firm
Integra LifeSciences Corp. (NeuroSciences)
Event
Event 97404
Status
Ongoing
Classification
Class II
Quantity
111492 units
Official record key
device-enforcement:Z-2512-2025

Official wording

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

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

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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach in the sterile barrier