FDAClass II · Medical device · Recalled June 10, 2026

Brand Name recall — B Braun Medical Inc

Hazard: B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2270-2026
Brand: B Braun Medical
Classification: Class II
Units affected: 390
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software Version: N/A Product Description: SESK UPMC DOUBLE CATHETER TRAY Component: No

Affected products

Brand Name

Companies & origin

Recalling firm location: Bethlehem, PA, United States
Firm address: 824 12th Ave, 18018-3524

Identifying details (verbatim from the notice)

Product codes / lots: Lot Code: Model No 530134, UDI-DI (Primary Device) 04046964305856, UDI-DI (Unit Device ID) 04046964305849, Lot Number 0062019148
Distribution: US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
Firm notified the public via: Letter
FDA event ID: 98862
Recall initiated: January 29, 2026
FDA classified: May 29, 2026
FDA report date: June 10, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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