# Class II recall Z-0067-2027: Custom Interventional Pain Management, LLC

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0067-2027 |
| Recalling firm | Custom Interventional Pain Management, LLC |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM  Product Name: Mastisol Skin Adhesive  Model/Catalog Number: 24161B (Ferndale and Medline); Tray 17025 17g continuous PBN tray (CIPM)  Software Version: n/a  Product Description: Skin Adhesive in a narrow plastic sterilized tube. Mastisol is a skin glue often used during surgical procedures.  Continuous epidural trays are designed for use by anesthesiologists and radiologists in the administration of  regional anesthesia.  Component: surgical kits |
| Reason | Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits. |
| Quantity | 56 |
| Distribution | U.S. Nationwide distribution in the state of TX. |
| Recall initiated | 2026-01-15 |
| Reported | 2026-10-07 |
| Firm location | San Antonio, TX, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 29 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0067-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.