MediHoney® 31612Recalls & reported problems

Acell, Inc. · MEDIHONEY® (NON -ADHESIVE) HYDROGEL COLLOIDAL SHEET with LEPTOSPERMUM HONEY WOUND & BURN DRESSING · Class U

All models of MediHoney (16)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Aug 5, 2025Class IIOpen, Classified
Packaging failures were identified which could lead to a breach in the sterile barrier.
Z-2507-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Device details

UDI-DI	`10381780486947`
Brand	MediHoney®
Model	31612
Company	Acell, Inc.
Product code	FRO · Dressing, wound, drug
Class	Class U
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 8, 2023

Device type (GMDN): Wound-nonadherent dressing, permeable, antimicrobial

A wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin, and that contains an antimicrobial agent (e.g., silver (Ag), honey). Its pores permit the drainage of exudates from, and application of medication to, the wound. This device may be used with other wound-care products to help heal chronic/infected and postoperative wounds, burns, skin grafts, cuts, or abrasions; it is not a dedicated burn dressing. This is a single-use device.

Other Dressing, wound, drug devices

MediHoney® 31815
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2 recalls7 reports
MediHoney® 31515
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2 recalls6 reports
MediHoney® 31805
Acell, Inc. · Dressing, wound, drug
2 recalls1 death5 reports
MediHoney® 31535
Acell, Inc. · Dressing, wound, drug
2 recalls0 reports
AQUACEL AG FOAM 420681
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99 reports
SteriCare Solutions 6240
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MEDLINE MNK0005
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1 recall5 reports
Medline DYND500MLS
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1 recall5 reports

All Dressing, wound, drug devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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