Open, Classified

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

FDA Recall Z-0067-2027 · Posted 2026-10-01

Recalling FirmCustom Interventional Pain Management, LLC

Recall StatusOpen, Classified

Product CodeOGE

Date Initiated2026-01-15

Product Quantity56

Reason for Recall

Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.

Firm Action

On 01/15/2026, a customer notification letter was email to a single customer informing them that, the MASTISOL Liquid adhesive shipped in kits in lot 1225271, P.O.#2513972 was exposed to a double sterilization cycle by Ferndale Laboratories, Inc. which may contribute to the butyrate tubing being brittle and cracking during actuation. The customer was instructed to: 1. lmmediately examine your inventory and quarantine Lot 1225271. 2. Return all units of MASTISOL in Lot 1225271 to: CIPM 12460 Network Blvd. Suite 106 San Antonio, TX 78249 3. Complete the enclosed Return Materials Authorization Form QF-85-05-02 and return to [email protected] or [email protected]. For questions - call Toll Free 1-888-392-4514

Root Cause

Process control

Distribution Pattern

U.S. Nationwide distribution in the state of TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.