FDA recall, , Moderate risk
MediHoney Gel and Calcium Alginate Dressings
MediHoney dressings and gel may have packaging failures that could breach the sterile barrier.
Summary by Recall Canary from the FDA notice
What happened
Integra LifeSciences Corp. (NeuroSciences) of Princeton, New Jersey began a recall on January 16, 2026, of MediHoney Gel with Active Leptospermum Honey, Private Label CVS, and Medihoney Calcium Alginate with Active Leptospermum Honey due to potential packaging failures that could lead to a breach in the sterile barrier.
The recall was added to the FDA's Enforcement Report and classified on February 13, 2026, and in FDA's weekly enforcement report on February 25, 2026.
Distribution was worldwide, including U.S. states such as Texas, Michigan, Florida, Indiana, Missouri, California, Virginia, New Jersey, Pennsylvania, South Carolina, Tennessee, Rhode Island, and New York, as well as countries like Australia, Canada, France, Germany, and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Affected if its UDI-DI, lot code and model number are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
MediHoney Calcium Alginate with Active Leptospermum Honey. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MediHoney Calcium Alginate Dressing with Active Leptospermum Honey Supports and Aids Autolytic Debridement and
- UDI-DI
- 10381780486909
- 10381780486916
- 10381780486923
- Lot code
- A24008
- A24057
- B21123
- B24075
- C22159
- C23177
- C24148
- D24190
- E21365
- E24254
- E24255
- G23393
- H21523
- H22452
- H23443
- I22512
- I23464
- J21693
- L22706
- 31022
- A23045
- A23065
- A25028
- A25056
- B23079
- B25068
- B25077
- C21151
- C21152
- C21155
- C21195
- C22182
- C22196
- C23183
- C23193
- C25152
- D23196
- D23208
- E21300
- E22305
- E22319
- F21407
- F21428
- F21430
- F22333
- F24317
- G23405
- H21544
- H22438
- H23415
- H23442
- H23446
- H24415
- I21610
- I21617
- J22530
- J23551
- J23560
- J24622
- K21723
- K21739
- K24625
- K24646
- L21838
- 31045
- A21056
- A22036
- A22047
- A24036
- B21062
- B21084
- B21100
- B21107
- B21119
- B25110
- D21229
- D21247
- D22251
- D22270
- D22275
- D23236
- D23248
- D24192
- D24220
- E21314
- E21337
- E21361
- E22277
- E23253
- E23271
- E24296
- F21376
- F22361
- F22362
- F22382
- F23369
- F23370
- G21490
- G21504
- G22385
- G23384
- H21506
- H21512
- H21530
- H23450
- H23451
- I22479
- I22481
- I22495
- I23466
- I23498
- I24511
- I24523
- J21680
- J21691
- K21777
- K21801
- K21806
- K22597
- K22609
- K22632
- K22663
- K24650
- K24679
- L21812
- L21823
- L22674
- L22711
- L23649
Private Label CVS.
- Model
- CVS405406
- UDI-DI
- 00050428452547
- Lot code
- 2428
- 2446
- 2509
- 2514
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and
- UDI-DI
- 10381780486978
- 10381780486886
- Lot code
- 2407
- 2408
- 2419
- 2425
- 2429
- 2430
- 2442
- 2443
- 2444
- 2445
- 2446
- 2449
- 2450
- 2502
- 2513
- 2515
- 2516
Recall details
- Company began the recall
- Sold in
- 13 states and 2 territories
- the U.S. Virgin Islands
Worldwide - US Nationwide distribution in the states of Texas, Michigan, Florida, Indiana, Missouri, California, Virginia, New Jersey, Pennsylvania, South Carolina, Tennessee, Rhode Island, New York and the countries of Australia, Austria, Bahrain, Canada, Finland, France, Germany, Greece, Guam, Guernsey, Hungary, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Korea (the Republic of), Kuwait, Lebanon, Madagascar, Malaysia, Netherlands (the), New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Tunisia, Uganda, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the), Virgin Islands (U.S.).
- Company
- Integra LifeSciences Corp. (NeuroSciences)Princeton, New Jersey
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98175
- Recall numbers
- Z-1363-2026 to Z-1365-2026
All recalls from Integra LifeSciences Corp. (NeuroSciences)
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
