B Braun Medical Inc recalls Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK

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.

On January 29, 2026 and May 6, 2026 URGENT MEDICAL DEVICE RECALL letters were sent to customers to notify them of a recall of a kit component. Actions to be taken include to review inventory to identify affected product, discontinue use and segregate. Using the acknowledgement form, respond to B Braun who will send further instructions to return the product. Should there be any questions, comments, or concerns regarding the product you have received, please feel free to contact (844-903-6417) or recalls@bbraunusa.com;

• FDA enforcement recordOfficial FDA database entry for Z-2264-2026
• FDA device classification · CAZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5140The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find B Braun Medical IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.