CLASS II ONGOING Device recall · Reported 10 Sep 2025 · FDA Enforcement Report
CVS Honey Pad recalled by Integra LifeSciences Corp.
Integra LifeSciences Corp. (NeuroSciences) is recalling CVS Honey Pad, distributed nationwide in the US. The recall was initiated on 5 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2512-2025
- FDA event ID
- 97404
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Aug 2025
- FDA classified
- 3 Sep 2025
- Reported
- 10 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 5 Aug 2025 | Recall initiated by company | |
| 3 Sep 2025 | Classified by FDA | +29 days |
| 10 Sep 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Packaging failures were identified which could lead to a breach in the sterile barrier.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Stores named: CVS
Questions about this recall
Why was it recalled?
Packaging failures were identified which could lead to a breach in the sterile barrier.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 97404This product is part of a recall event; the main page for the event is MediHoney¿ Paste recalled by Integra LifeSciences Corp..
More recalls from Integra LifeSciences Corp. (NeuroSciences)
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|---|---|---|---|---|---|
| Device | CLASS II | OmniTract Surgical Retractor System recalled | Integra LifeSciences Corp. (NeuroSciences) | Sterility | Nationwide |
| Device | CLASS II | Codman CerebroFlo EVD Catheter with Endexo Technology recalled | Integra LifeSciences Corp. (NeuroSciences) | Other | Nationwide |
| Device | CLASS II | CUSA Clarity C7000 Console recalled by Integra LifeSciences Corp. | Integra LifeSciences Corp. (NeuroSciences) | Device Malfunction | Nationwide |
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| Device | CLASS II | Cytal Wound Matrix 2-Layer cm. Product ID: WSM0710 recalled | Integra LifeSciences Corp. (NeuroSciences) | Other | Nationwide |
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