Z-2512-2025Class II

Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product...

Name: Z-2512-2025 Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product...
Creator: Integra LifeSciences Corp. (NeuroSciences)
Published: 2025-08-05
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2025-08-05 / Open, Classified / root cause: packaging

FDA source

Integra LifeSciences Corp. (NeuroSciences) began a recall of Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey... on 2025-08-05. FDA classified it as Class II and gives the reason as "Packaging failures were identified which could lead to a breach in the sterile barrier". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2512-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-05
Posted: 2025-09-03
Recalling firm: Integra LifeSciences Corporation
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.
Product code: FRO Dressing, Wound, Drug
Reason for recall: Packaging failures were identified which could lead to a breach in the sterile barrier.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On August 5, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions for Customers: If you have units of the impacted product remove them immediately from service and quarantine them. Forward this notice to those who utilize the product so they are aware of this recall and can identify any affected product that may remain in clinical areas. Complete the entirety of the Acknowledgement Form and send via email to [email protected] or FAX to 1-609-750-4220. Keep a copy of the form for your records. Actions for Distributors: If you have products listed in Table 1, remove the product from further distribution. Complete the entirety of the Acknowledgement Form and send via email to [email protected] or FAX to 1-609-750-4220. Keep a copy of the form for your records. Check your customer traceability records and notify them if they have any shipments of above catalog and lot numbers. Modify the acknowledgement form to create one from you to your customers. Collect completed response forms and affected product from your customers and indicate total quantities and lots in distributor reply form. For questions regarding these instructions, please contact Customer Service: Monday - Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873 email: [email protected] Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Integra is dedicated to patient safety and manufacturing excellence. We continue to make numerous quality improvements and investments in our facilities around the world. In addition, we are improving our processes in accordance with applicable regulations. We sincerely apologize for any inconvenience this voluntary recall may cause and thank you for your cooperation in this effort.
Quantity in commerce: 111492 units
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2512-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2505-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03
Z-2506-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03
Z-2507-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03
Z-2508-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03
Z-2509-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03
Z-2510-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03
Z-2511-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03
Z-2512-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03

Product code FRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)