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General product information only, not medical advice. This page does not describe how to apply or remove any adhesive.
Short answer
Mastisol is a brand of liquid adhesive made by Ferndale Laboratories, Inc. In the device databases of the FDA and the NIH National Library of Medicine it is listed as a “Tape And Bandage, Adhesive” (product code KGX), exempt from premarket submission, over-the-counter, single-use and not packaged as sterile. Its 2/3 mL vial, catalog number 0523-48, had a Class 2 recall for one lot, 24161B.
Definition and scope
A liquid skin adhesive of this kind is an adjunct: it is intended to hold another product, such as a dressing or device, against the skin. The GMDN definition shown in the NIH AccessGUDID record describes the device type as “A sterile substance (e.g., gel, aerosol) intended to adhere a medical device” to the skin surface. That is a different job from closing a wound, which is covered by tissue adhesive pages, and from sealing a thin film over minor skin breaks, covered in how liquid bandage works.
This page names Mastisol because it is the product people search for. Other manufacturers sell liquid adhesives for the same purpose, and the regulatory points below describe this one product record, not every liquid adhesive.
How it is described in practice (FDA and NLM records)
The AccessGUDID record for Mastisol (device identifier 00304960523488, checked 2026-10-30) gives the device description “LIQUID ADHESIVE”, brand MASTISOL, company Ferndale Laboratories, Inc., and the following attributes:
- FDA product code KGX, “Tape And Bandage, Adhesive”.
- Device exempt from premarket submission: yes.
- Single-use: yes. Prescription use: no. Over-the-counter use: yes.
- Device packaged as sterile: no.
- Commercial distribution status: in commercial distribution.
- No MRI safety information in the labeling.
Application and removal directions come from the manufacturer instructions for use for the specific package in hand, and are deliberately not reproduced here.
Types and related concepts
Skin-contact products that are easily confused sit in different groups. Each row below points to the CASRAI page that covers it.
| Product group | What the sourced record or page says | CASRAI page |
|---|---|---|
| Liquid adhesive (Mastisol record) | Intended to adhere a medical device to skin; KGX; not packaged sterile; OTC; single-use (AccessGUDID, 2026-10-30) | this page |
| Liquid bandage | Covered on its own page | How does liquid bandage work |
| Skin tissue adhesive | Closure-type products, covered on their own page | Dermabond and Prineo |
| Skin barrier film | Covered on its own page | What is Cavilon |
| Medical tape reactions | Covered on its own page | Allergic reaction to medical tape |
Where it matters for labs, clinics and supply decisions
The most concrete, checkable supply fact is the recall record. In the FDA medical device recall database (checked 2026-10-30), recall number Z-1005-2026 is a Class 2 recall, initiated 25 November 2025 and posted 31 December 2025, for “Mastisol Liquid Adhesive”, catalog number 0523-48, described as a 2/3 mL vial, 48 vials per carton. It covers lot 24161B only. The stated reason is “Butyrate tube cracks during actuation, rendering product unusable.” FDA classifies the cause as process control. Ferndale Laboratories instructed consignees to quarantine the lot and return units; the record lists 24,589 units distributed in the United States and the United Kingdom.
Receiving and stock check list
- Compare the catalog number on the carton with 0523-48.
- If it matches, read the lot number and compare it with 24161B.
- Keep the recall number Z-1005-2026 in the quarantine and return record.
- The record says the product is not packaged as sterile; do not file it with sterile supplies on the assumption that it is.
- Check the FDA recall database again before relying on this status: the entry was open and classified when checked.
Common misunderstandings
- “It is a wound-closure glue.” The record describes an adhesive for holding a dressing or device on skin, listed under tapes and bandages, not under a closure product.
- “The GMDN says sterile, so it is sterile.” The GMDN term text says “sterile substance”, but the same record states the device is not packaged as sterile. Follow the packaging record.
- “A recall means every Mastisol product is affected.” The Z-1005-2026 entry names one lot, 24161B, of the 2/3 mL vial.
FAQ
What is Mastisol?
A brand of liquid adhesive from Ferndale Laboratories, Inc., listed in AccessGUDID as a liquid adhesive for adhering dressings and devices to skin.
Is Mastisol available over the counter?
The AccessGUDID record marks it as over-the-counter, not prescription, and in commercial distribution as of 2026-10-30.
Is Mastisol sterile?
No. The record states “Device Packaged as Sterile: No”.
Was there a Mastisol recall?
Yes. FDA recall Z-1005-2026 (Class 2) concerns lot 24161B of catalog number 0523-48 because the tube could crack during actuation.
Sources
- NIH National Library of Medicine, AccessGUDID record for MASTISOL, device identifier 00304960523488: accessgudid.nlm.nih.gov/devices/00304960523488 (checked 2026-10-30).
- U.S. FDA, Medical Device Recalls database, recall Z-1005-2026: accessdata.fda.gov recall record 217465 (checked 2026-10-30).
