FDA DevicesClass II
Medline EBSI Kit EBSI1534
Published: June 24, 2026Recall ID: Z-2414-2026Category: devicesCountry: US
Reason for Recall / Hazard
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Product Description & Identification
Medline EBSI Kit EBSI1534
Affected Products
Medline EBSI Kit EBSI1534
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98951 |
| Address 1 | 3 Lakes Dr |
| Code info | UDI-DI 10653160350507 Lot 2025110490 |
| Postal code | 60093-2753 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 49,654 kits total |
| Reason for recall | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260427 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260612 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution. OUS distribution pending.