Custom Interventional Pain Management Mastisol Skin Adhesive and Continuous Epidural Trays
Mastisol Skin Adhesive has manufacturing issues with the liquid adhesive in surgical trays.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Custom Interventional Pain Management, LLC recalled Mastisol Skin Adhesive in surgical convenience trays/kits due to manufacturing issues with the liquid skin adhesive. The recall began on January 15, 2026, and was added to the FDA's Enforcement Report on October 1, 2026.
Summary by Recall Canary from the FDA notice.
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?
Affected if its model number and lot code are listed under that product.
Mastisol Skin Adhesive
- Model
- 24161B
- Tray 17025 17g continuous PBN tray
- Lot
- 17025
- 27022
- 1225271
- 64591
Details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the state of Texas.
- Event ID
- 99699
- Recall No.
- Z-0067-2027
- Company
- Custom Interventional Pain Management, LLCSan Antonio, Texas
- Hazard
- Manufacturing deviation
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
