Official recall notice

FDA DeviceClass IINotable

Mastisol Skin Adhesive Recall (Oct 2026)

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

Recall date
2026-10-07
FDA class
Class II

Why it was recalled

Hazard

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

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Product description

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

Affected products

Lot Code: CIPM product / reorder #17025; Description: 17g continuous PBN tray; Item #110026; Received Lot# 27022; Affected Lot #1225271; Expiration Date: 01/31/2028; DHR or Batch Record #64591; UDI: *+B87517LIDO/$$20131281225271T* UDI- DI #: B87517LID0 with Lidocaine

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