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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

MediHoney and CVS Honey Pad Dressings Recalled for Sterile Barrier Breach

Agency Publication Date: September 3, 2025
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Summary

Integra LifeSciences is recalling 279,655 units of various MediHoney wound care dressings and CVS Honey Pads due to identified packaging failures. These failures could lead to a breach in the sterile barrier of the products, which are used to maintain a moist environment for wound healing and to support autolytic debridement. The recall includes pastes, tubes, and multiple types of hydrogel and surgical adhesive sheet dressings. Consumers and healthcare professionals are advised to stop using the affected products immediately to prevent potential health risks.

Risk

A breach in the sterile barrier can expose the medical-grade honey dressing to environmental contaminants. Using a non-sterile dressing on a wound increases the risk of serious infection, which could complicate the healing process and lead to further medical issues.

What You Should Do

  1. This recall affects multiple versions of MediHoney wound dressings—including Paste, Tube, HCS Sheet Dressing, Adhesive Hydrogel Sheet Dressing, and Surgical Adhesive Sheets—as well as CVS Honey Pads.
  2. Identify your product by checking the brand name and the catalog or model number on the packaging. Affected catalog numbers include 31505, 31515, 31535, 31612, 31622, 31644, 31720, 31740, 31620, 31640, 31722, 31744, 31738, 9370613, and 937404.
  3. Check the lot number and Unique Device Identifier (UDI) printed on the product label or outer box. Because this recall involves a large volume of production codes, see the Affected Products section below for the full list of affected codes.
  4. Stop using the product immediately. Return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or Integra LifeSciences Corp. for further instructions.
  5. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

💰Option 1: Full Refund
How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement
🗑️Option 2: Dispose of Product
How to: Stop using and throw the product away.

Affected Products

Product: MediHoney Paste
Variants: Active Leptospermum medical grade Honey
Model / REF:
31505
Lot Numbers:
2150
2336
2151
2337
2201
2414
2209
2415
2217
2417
2232
2428
2241
2434
2301
2435
2312
2505
2313
2508
2314
2509
2328
UDI:
10381780486930

Helping maintain a moist environment conducive to wound healing.

Product: MediHoney Tube
Variants: Active Leptospermum medical grade Honey
Model / REF:
31515
31535
Lot Numbers:
2123
2211
2124
2212
2127
2213
2128
2222
2129
2223
2132
2232
2133
2233
2137
2243
2136
2244
2143
2309
2150
2307
2210
2108
2242
2116
2306
2313
2315
2138
2333
2139
2339
2201
2404
2209
2423
UDI:
10381780486824
10381780486831
Product: MediHoney HCS Sheet Dressing with Leptospermum
Variants: Hydrogel colloidal gelling agent, 63% Leptospermum Honey
Model / REF:
31612
31622
31644
Lot Numbers:
D034323
50623
45022
34023
41223
50423
10323
54223
42323
UDI:
10381780486947
10381780471356
10381780471363
Product: MediHoney Adhesive Hydrogel Sheet Dressing
Variants: Adhesive border, 100% Leptospermum Honey
Model / REF:
31720
31740
Lot Numbers:
14422
33324
11524
10224
23124
42423
UDI:
10381780471417
10381780471424
Product: MediHoney Hydrogel (Non-Adhesive)
Variants: 100% Leptospermum Honey
Model / REF:
31620
31640
Lot Numbers:
30623
40724
25022
23823
54922
24123
54322
54023
23024
43823
13424
24423
53424
11323
51324
10823
20224
30823
24623
33524
34523
UDI:
10381780471370
10381780471400
Product: MediHoney Hydrogel Adhesive Sheet
Variants: 63% Leptospermum Honey, Adhesive border
Model / REF:
31722
31744
Lot Numbers:
44422
14223
50423
12523
UDI:
10381780471387
10381780471394
Product: MediHoney HCS Surgical Adhesive Sheet
Variants: Surgical grade, Adhesive border
Model / REF:
31738
Lot Numbers:
53824
UDI:
10381780486961
Product: CVS Honey Pad
Variants: Infused with natural medical-grade honey
Model / REF:
9370613
937404
UPC Codes:
0050428462584
Lot Numbers:
024622
014622
044622
020923
040923
054623
020124
014524
UDI:
00050428510377
0050428462584

UDIs are owned by CVS.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97404
Status: Active
Manufacturer: Integra LifeSciences Corp. (NeuroSciences)
Sold By: CVS; Authorized Dealers; Specialty Retailers
Manufactured In: United States
Units Affected: 8 products (15441 units; 141620 units; 3583 units; 994 units; 5374 units; 1147 units; 4 units; 111492 units)
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.